MalfunctionPZI
STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
Received Apr 22, 2026 · Event occurred Mar 26, 2026
Report 1219029-2026-00025 · MDR key 24958011
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
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
PER CUSTOMER "REPLACEMENT METERS RECENTLY RECEIVED ARE LOSING CONNECTION TO THE NETWORK AND SERVER AND ATTEMPTING TO CONNECT TO THE HOSPITAL GUEST WIFI. THIS IS CAUSING A SIGNIFICANT DELAY IN RESULTS REACHING THE CHART AND IMPACTING PATIENT CARE."
Additional Manufacturer Narrative
AN INVESTIGATION INTO THE ROOT CAUSE OR THE REPORTED ISSUE HAS BEGUN BUT IS NOT YET COMPLETED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.