Prescription Use Blood Glucose Meter For Near-Patient Testing
FDA adverse event reports and recall history for prescription use blood glucose meter for near-patient testing (product code PZI), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 135
- Deaths
- 2
- Injuries
- 3
- Malfunctions
- 130
Reports per year
Source: FDA adverse event reports by year received, 2019–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2024-12-20Open, ClassifiedSoftware design
StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.
A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to transmission of erroneous glucose patient test results to a healthcare institution's data management system (DMS) at healthcare sites using WiFi if a user navigates to the Review Results screen while the meter is in the process of transmitting the current glucose test result to the DMS. The risk of this software defect is erroneously high or low glucose results being documented in a patient's medical record, which may lead to incorrect treatment.
Monitor prescription use blood glucose meter for near-patient testing automatically
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