Abbott Diabetes Care in the US have been warned by the Food and Drug Administration (FDA), after recent concerns over manufacturing violations involving the firm’s blood glucose monitoring systems. These are used by diabetics to monitor their blood sugar levels.
Following an inspection of Abbott’s facility in Alameda, California, where they make the FreeStyle glucose-monitoring and the Navigator continuous-monitoring systems, the FDA reported that the company had failed to ensure proper quality control testing and inspection procedures. The FDA said Abbott didn’t follow the correct procedures when correcting problems, including as scratches found on some FreeStyle Lite monitoring strips and empty blister packs.
Abbott were also reported to fail to provide the necessary education, background, training and experience to staff in key positions, and that it didn’t have sufficient qualified personnel to ensure that manufacturing processes met agency standards.
Abbott Diabetes Care commented that had “taken and continues to take the actions necessary to address the items outlined in the letter and is communicating those actions directly to the agency.”
In May this year, the FDA announced a recall of the FreeStyle Navigator Continuous Glucose Monitoring System due to the possibility that cracks in its plastic housing could let in moisture and trigger device failure or inaccurate readings. The FDA had previously warned Abbott and other manufacturers about their glucose GDH-PQQ test strips, as there was a risk if they contained sugars other than glucose, which could pose a threat to patients with diabetes using them. These test strips can react with non-glucose sugars such as maltose to produce a falsely high glucose reading, which might cause patients with diabetes to take too much insulin .

Get our free newsletters

Stay up to date with the latest news, research and breakthroughs.

You May Also Like

Public Health England considers low carb approach for type 2 diabetes

The low carb approach is being considered by the government to be…

Coronavirus: UK instructed to stay at home this weekend

Health Secretary Matt Hancock has said that staying at home this weekend…

Type 2 diabetes found to be a ‘significant risk factor’ among stroke victims

More evidence has been published which supports that diabetes is a “significant…