STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
Received Mar 3, 2026 · Event occurred Feb 1, 2026
Report 1219029-2026-00014 · MDR key 24500277
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
THE DEVICE IN QUESTION IS A STATSTRIP GEN2 GLUCOSE METER. HOWEVER, THE SPECIFIC SERIAL NUMBER WAS NOT PROVIDED. TECHNICAL SUPPORT WAS ABLE TO MANUALLY TRANSMIT THE STUCK RESULT, WHICH REMOVED THE BACKLOG OF RESULTS. AN INVESTIGATION INTO THE ROOT CAUSE OF THE REPORTED ISSUE HAS BEGUN BUT IS NOT YET COMPLETED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
RESULT FROM STATSTRIP GEN 2 METER TRANSMITTED TO CUSTOMER'S MIDDLEWARE STUCK IN "PENDING" STATUS WHICH PREVENTED OTHER RESULTS FROM CROSSING TO PATIENTS CHART. ALTHOUGH THERE WERE NO SPECIFIC ALLEGATIONS OF DELAYS IN TREATMENT, THIS ISSUE COULD POTENTIALLY LEAD TO DELAYS.