Nova Biomedical Corporation: Prescription Use Blood Glucose Meter For Near-Patient Testing
Updated 5 hours ago ()
A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) barcodes and quality control (QC) solution ID barcodes when a new barcode is scanned, resulting in the prior barcode information remaining displayed on the screen for the current test. When this defect occurs and the operator accepts the incorrectly displayed patient information without recognizing the mismatch, the current patient's glucose result will be incorrectly assigned to the previous patient's medical record and transmitted to the data management system (DMS), and the current patient's medical record will not receive a result, leaving their glucose status unrecorded and their clinical management without the information needed to guide treatment decisions. The previous patient, whose medical record now contains a glucose result that does not belong to them, may receive inappropriate clinical intervention based on that erroneous result, particularly in critically ill patients, neonates, and infants who cannot communicate symptoms or self-treat. The defect also a
- Tags
- FDA recall, medical device, class 2, Clinical Chemistry, Software design, Open, Classified
- Related exam domains
- CISSP 3: Security Architecture and Engineering; CISSP 6: Security Assessment and Testing; CISSP 8: Software Development Security; CISM 3: Information Security Program
- Source record id
- Z-3130-2026
- First seen by InfoSec Signals
- Sep 23, 2026
Source: openFDA device recalls, U.S. Food and Drug Administration about this source more from it
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