MalfunctionPZI
STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
Received Jan 2, 2026 · Event occurred Dec 10, 2025
Report 1219029-2026-00001 · MDR key 23949611
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
INVESTIGATION BEGUN BUT NOT YET COMPLETED. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
METER ACCEPTED A PATIENT RESULT AND SHOWS ON THE METER THAT THE RESULT WAS INDEED ACCEPTED. INSIDE OF NOVANET (METER SOFTWARE) AND QML (MIDDLEWARE) THIS RESULT SHOWS THAT IT WAS NOT ACCEPTED ON THE METER. THUS PREVENTING THE RESULT FROM GOING TO THE PATIENTS CHART. THIS COULD HAVE LED TO POTENTIAL DELAYS IN TREATMENT.