The FDA has issued its most serious recall classification for certain hospital glucose meters after a software issue that could cause test results to be assigned to the wrong patient was linked to one serious injury.
The recall affects Nova Biomedical’s StatStrip Glucose Hospital Meter System Gen 2.0, a handheld device used by hospitals to measure patients’ blood glucose levels.
According to the FDA, the software issue can cause previously scanned patient identification information to remain on the meter’s screen. If a clinician accepts that information, the resulting glucose measurement could be assigned to the wrong patient’s electronic medical record.
The issue does not affect the accuracy of glucose measurements, but it could lead clinicians to make treatment decisions based on another patient’s results, potentially causing delayed treatment, unnecessary treatment or inappropriate insulin administration.
The FDA warned that critically ill patients and infants, who may be unable to communicate symptoms of low blood sugar, face a greater risk of harm.
As of Oct. 5, Nova Biomedical had reported one serious injury and no deaths associated with the issue.
The recall affects all firmware versions of the Gen 2.0 model but does not include earlier generations of the StatStrip system.
Nova Biomedical initially notified affected customers July 31 and updated its recommendations Oct. 5. The company has placed a shipment hold on new Gen 2.0 meters while developing and validating a software fix, which it expects to begin rolling out in phases in November.
The FDA said affected meters should be removed from use when an alternative device is available. Facilities without alternatives should follow interim safety measures, including verifying patient identification before and after testing, configuring automatic operator logouts and correcting any glucose results assigned to the wrong medical record.
The agency classified the recall as the most serious type, indicating that continued use of affected devices could cause serious injury or death.
Becker’s 3rd Annual Fall Chief Pharmacy Officer Summit is the top tier event that the people leading the future of pharmacy convene. This 3-day event is built specifically for Chief Pharmacy Officers and senior pharmacy leaders. The sessions examine the workforce, financial and clinical priorities shaping pharmacy today. Becker’s is where candid discussions flourish and new ideas thrive. Becker's 3rd Annual Fall Chief Pharmacy Officer Summit
