Pattidevans
Well-Known Member
In May this year I was concerned about the post prandial spikes I was having. If I took enough rapid to iron them out I was going hypo later on before my Novorapid had finished working. I understood that Apidra had a faster peak and less of a tail so I asked to change to Apidra. My nurse was in agreement and prescribed me a box of five Solostar pens. I checked specifically to ensure that the Novofine needles I was using were compatible with the Solostar pen and was assured that they were.
When I started using the pens I noticed a severe leakage when withdrawing the needle from my abdomen. I had never noticed this with Novorapid flexpen or the Novopen 4, nor with Levemir pre filled pens (or indeed, previously when I was using the Optiset pen with Lantus). I continued to use the Apidra Solostar pen for approximately three days, during which time my BGs were raised and by this time I was completely convinced that this was because I was not getting full delivery of the dialled dose. I was, however, unsure as to exactly by how much the dose fell short. I telephoned my nurse and after consulting with her I started on a fresh pen. Just in case, I placed the original pen back in the fridge.
The problem persisted with the fresh pen and after a week I was becoming very stressed because I always strive for very tight control of my BG. I then decided to see if I could accurately measure the leakage, so after injecting myself I caught the drips into a needle cap. I then primed my Levemir pen and shot various doses into another needle cap until the amount measured the same as the leakage from the Apidra pen. After some experimentation I decided that the Apidra pen was consistently leaking give or take 3u insulin.
On 4th June I telephoned Sanofi Aventis and told them that I thought I had a batch of faulty pens. The customer service person asked if I had been suffering high BGs and I responded that I had because the dose of insulin I was receiving was falling short of the amount needed to cover the carbs I was eating. She advised me to send all the pens in the batch back and said she would send me suitable packaging and labelling. Fortunately I had a cartridge of Novorapid as a standby until I could obtain a new presciption.
Some while later I received a letter from Sanofi Aventis along with a form giving them permission to contact my doctor to ask for my full medical history, current condition and medication. I did sign the consent form, but returned it to them along with a letter explaining that I was not complaining about Apidra insulin per se, but about a faulty injection device. At a subsequent diabetic review my nurse showed me the letter that they had written to my Dr. asking for the details mentioned. In my opinion this was unnecessary.
I received a further letter from Sanofi Aventis dated 30th September. The pertinent paragraph is quoted below:-
“The manufacturing records were reveiwed for this batch and no anomalies or faults were identified. The returned samples were inspected and non-centric penetration marks were visible on the membranes of some of the samples, indicating that the needle had not been centrally mounted. It is recommended that the needle is centrally mounted in order to ensure correct functioning of the device and to avoid the occurrence of leakage”
The letter also suggested that I should receive further training from my Device Specialist Nurse. In other words they are saying it was user error and implying that I do not know how to screw a needle onto an insulin pen. Now, I have been injecting five times a day for the last five years minimum and prior to that twice a day. A total of thousands of needles screwed on and the only time I can recall having this leakage problem is for one week at every injection from the Solostar pen. I have not experienced it since and I do pride myself on accurately carb counting and injecting.
To quote a fellow diabetic “There's a fixed outer thread on to which the inner thread on the rigid-cased needle screws securely. The inner part of the needle that pierces the vial membrane when it's screwed on is recessed so it would only be possible to realign it significantly by inserting some sort of thin implement. To say it was screwed on off-centre is like a garage saying you put your wheel nuts on off-centre. Not easy to manage.”
I am, of course, rather annoyed by Sanofi Aventis’ response and implication that it was my own inept application of their device, but it brings me to a rather more serious issue. Although Apidra isn’t as popular as other rapid insulins, the Solostar pen is also used for Lantus. In diabetic forums that I read, and post in, I have noticed that many people come in having problem with their basal levels and this just leads me to wonder exactly how many of them are affected by inaccurate dosage from this particular pen. I have heard from another diabetic who says that when she was on Lantus she was concerned as to why her basal rates were so skewed, that she had contacted the manufacturer in the US and been sent a 3 page interrogation of her injection techniques (after which she heard nothing).
I would like to say “wake up Sanofi Aventis” and pay a little more attention to the people who’s health you may be affecting. Try treating them like responsible adults and take notice of their feedback to improve your product”. Incidentally I switched back to Novorapid and wouldn’t try Apidra again unless it came in a much improved injection device.
When I started using the pens I noticed a severe leakage when withdrawing the needle from my abdomen. I had never noticed this with Novorapid flexpen or the Novopen 4, nor with Levemir pre filled pens (or indeed, previously when I was using the Optiset pen with Lantus). I continued to use the Apidra Solostar pen for approximately three days, during which time my BGs were raised and by this time I was completely convinced that this was because I was not getting full delivery of the dialled dose. I was, however, unsure as to exactly by how much the dose fell short. I telephoned my nurse and after consulting with her I started on a fresh pen. Just in case, I placed the original pen back in the fridge.
The problem persisted with the fresh pen and after a week I was becoming very stressed because I always strive for very tight control of my BG. I then decided to see if I could accurately measure the leakage, so after injecting myself I caught the drips into a needle cap. I then primed my Levemir pen and shot various doses into another needle cap until the amount measured the same as the leakage from the Apidra pen. After some experimentation I decided that the Apidra pen was consistently leaking give or take 3u insulin.
On 4th June I telephoned Sanofi Aventis and told them that I thought I had a batch of faulty pens. The customer service person asked if I had been suffering high BGs and I responded that I had because the dose of insulin I was receiving was falling short of the amount needed to cover the carbs I was eating. She advised me to send all the pens in the batch back and said she would send me suitable packaging and labelling. Fortunately I had a cartridge of Novorapid as a standby until I could obtain a new presciption.
Some while later I received a letter from Sanofi Aventis along with a form giving them permission to contact my doctor to ask for my full medical history, current condition and medication. I did sign the consent form, but returned it to them along with a letter explaining that I was not complaining about Apidra insulin per se, but about a faulty injection device. At a subsequent diabetic review my nurse showed me the letter that they had written to my Dr. asking for the details mentioned. In my opinion this was unnecessary.
I received a further letter from Sanofi Aventis dated 30th September. The pertinent paragraph is quoted below:-
“The manufacturing records were reveiwed for this batch and no anomalies or faults were identified. The returned samples were inspected and non-centric penetration marks were visible on the membranes of some of the samples, indicating that the needle had not been centrally mounted. It is recommended that the needle is centrally mounted in order to ensure correct functioning of the device and to avoid the occurrence of leakage”
The letter also suggested that I should receive further training from my Device Specialist Nurse. In other words they are saying it was user error and implying that I do not know how to screw a needle onto an insulin pen. Now, I have been injecting five times a day for the last five years minimum and prior to that twice a day. A total of thousands of needles screwed on and the only time I can recall having this leakage problem is for one week at every injection from the Solostar pen. I have not experienced it since and I do pride myself on accurately carb counting and injecting.
To quote a fellow diabetic “There's a fixed outer thread on to which the inner thread on the rigid-cased needle screws securely. The inner part of the needle that pierces the vial membrane when it's screwed on is recessed so it would only be possible to realign it significantly by inserting some sort of thin implement. To say it was screwed on off-centre is like a garage saying you put your wheel nuts on off-centre. Not easy to manage.”
I am, of course, rather annoyed by Sanofi Aventis’ response and implication that it was my own inept application of their device, but it brings me to a rather more serious issue. Although Apidra isn’t as popular as other rapid insulins, the Solostar pen is also used for Lantus. In diabetic forums that I read, and post in, I have noticed that many people come in having problem with their basal levels and this just leads me to wonder exactly how many of them are affected by inaccurate dosage from this particular pen. I have heard from another diabetic who says that when she was on Lantus she was concerned as to why her basal rates were so skewed, that she had contacted the manufacturer in the US and been sent a 3 page interrogation of her injection techniques (after which she heard nothing).
I would like to say “wake up Sanofi Aventis” and pay a little more attention to the people who’s health you may be affecting. Try treating them like responsible adults and take notice of their feedback to improve your product”. Incidentally I switched back to Novorapid and wouldn’t try Apidra again unless it came in a much improved injection device.
:roll: 