Glucose Hospital Meter Software Bug Transmits Inaccurate Results
StatStrip Glucose Hospital Meter software bug may transmit erroneous glucose values to healthcare systems, potentially leading to incorrect patient treatment. 2,365 units affected nationwide and internationally.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I medical device recall, which per the severity rubric requires a minimum score of 4. The device's software defect can transmit inaccurate glucose readings to hospital systems, potentially resulting in incorrect treatment decisions. No illnesses or deaths have been reported.
Plain-English summary
Nova Biomedical Corporation issued a recall of the StatStrip Glucose Hospital Meter System (Model 63685) due to a software bug in the device's firmware. Approximately 2,365 units have been affected.
The bug occurs when a user navigates to the Review Results screen while the meter is transmitting a glucose test result to a healthcare facility's data management system via WiFi. This causes erroneous glucose readings—either erroneously high or erroneously low values—to be transmitted and stored in the data system.
As a result, patients' medical records may contain inaccurate glucose values. Healthcare providers relying on these incorrect readings may make inappropriate treatment decisions. The affected meters were distributed nationwide throughout the United States as well as internationally to Germany, Italy, Israel, Switzerland, Australia, Great Britain, and the Netherlands.
Healthcare facilities using this device should implement measures to prevent users from navigating to the Review Results screen during data transmission and should review affected patient records for accuracy. Contact Nova Biomedical Corporation for further information.
The recalled product
- Product
- StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.
- Manufacturer
- Nova Biomedical Corporation
- Affected units
- 2,365
Distribution
Part of a larger recall action
This product is one of 3 recalled by Nova Biomedical Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Nova Biomedical Corporation
See all →- SevereNova Biomedical StatStrip Glucose Meter Recalled for Data Error
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