STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
Received Mar 12, 2026 · Event occurred Feb 10, 2026
Report 1219029-2026-00019 · MDR key 24580778
Device
Generic name
Prescription Use Blood Glucose Meter For Near-patient Testing
Manufacturer
Nova Biomedical Corp.Model number
2.0Catalog number
63685
Product problems
- Computer Software Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
TECHNICAL SUPPORT MANUALY TRANSMITTED THE STUCK RESULT WHICH REMOVED THE BACKLOG OF PENDING RESULTS. AN INVESTIGATION INTO THE ROOT CAUSE OF THE ISSUE HAS BEGUN BUT IS NOT YET COMPLETED. A SUPPLEMENTAL REPORT WILL BE ISSUED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
STATSTRIP GEN 2.0 METER TRANSMITTED THE SAME RESULT REPEATEDLY TO CUSTOMERS MIDDLEWARE, PREVENTING OTHER RESULTS FROM CROSSING INTO THE PATIENTS CHART. ALTHOUGH THERE WAS NO DIRECT ALLEGATION OF A DELAY IN TREATMENT, THERE IS A POTENTIAL FOR DELAYS WITH THIS ISSUE.