A hospital blood sugar meter made by Nova Biomedical can attach one patient's glucose result to another patient's medical record, the company has warned. In rare cases, the error could lead staff to give insulin to the wrong person or miss someone who needs treatment.
The company's notice, posted by the FDA on October 6, announces a global correction covering all serial numbers of the Gen 2.0 StatStrip Glucose Hospital Meter System. One U.S. adverse event has been reported, involving inappropriate insulin administration. No serious adverse events have been reported.