Nipro Diagnostics TRUEyou blood glucose test strips - risk of false low blood glucose results

(Nipro Diagnostics) TRUEyou blood glucose test strips - certain lots of test strips may give incorrect low blood glucose results that could lead to undetected hyperglycaemia (MDA/2016/009)

Action

• Identify patients who use TRUEyou and TRUEyou mini blood glucose meters
• Advise patients to discontinue use of any blood glucose test strips with affected lot numbers
• Return affected test strips to manufacturer for replacement
• Ensure that patients are aware of this information and that they have an alternative testing means, if required
• Ensure the patient can continue to monitor their blood glucose effectively
• If patients are concerned about their blood glucose readings when using this meter, advise them to contact their healthcare professional

Actions by

• Healthcare personnel managing patients who use these devices

Deadlines for actions
Actions underway: 7 July 2016, actions complete: 7 August 2016

Device details
TRUEyou blood glucose test strips



Product Name Item Number Lot Number Expiry Date
TRUEyou FAD E3I68-82FDL HLS1024GBY 28 April 2018
TRUEyou FAD E3I68-82FDL HLS1032GBY 22 June 2018
TRUEyou FAD E3I68-82FDL HLS1033GBY 23 June 2018
TRUEyou FAD E3I68-82FDL HLS1036GBY 24 June 2018
TRUEyou FAD E3I68-82FDL HLS1037GBY 20 June 2018
TRUEyou FAD E3I68-82FDL LS1303GBY 17 February 2018
TRUEyou FAD E3I68-82FDL LS1304GBY 17 February 2018
TRUEyou FAD E4GBY70FDL-24 HLS1037GBY 20 June 2018
Product Name Item Number Kit Lot Number Expiry Date
TRUEyou FAD E4I68-81FDL KS1222 28 April 2018
TRUEyou FAD E4I68-81FDL KS1223 28 June 2018
TRUEyou FAD E4I68-81FDL KS1570 22 June 2018
TRUEyou FAD E4I68-81FDL KS1575 28 April 2018
TRUEyou FAD E4I68-81FDL KS1784 22 June 2018
TRUEyou FAD E4I68-81FDL KS1785 23 May 2018
Problem/background
The manufacturer issued a Field Safety Notice (FSN) in May 2016. Some vials in specific lots are not sealed properly and this can affect the performance of the strips.

Manufacturer contacts
Manufacturer:

Customer Services
Nipro Diagnostics (UK) Limited

Telephone: 0148 84 194

Email: info-UKSO@nipro-europe.com

Read more: https://www.gov.uk/drug-device-aler...lse-low-blood-glucose-results-in-some-batches