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MalfunctionPZI

STATSTRIP GLUCOSE HOSPITAL METER SYSTEM

Received Feb 11, 2026 · Event occurred Jan 16, 2026

Report 1219029-2026-00012 · MDR key 24316751

Device

Generic name

Prescription Use Blood Glucose Meter For Near-patient Testing

Model number

1.86

Catalog number

54790

Product problems

  • Communication or Transmission Problem

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THIS ISSUE WAS ESCALATED TO THE NOVA CONNECTIVITY SUPPORT TEAM AND R&D. AFTER TROUBLESHOOTING THE TRANSMISSION PROBLEMS, AN ISSUE WITH THE CUSTOMER'S NETWORK SETTINGS WAS IDENTIFIED AND RESOLVED. THE METER SYSTEM WAS PERFORMING AS INTENDED. TECHNICAL SUPPORT CONFIRMED THAT ALL THEIR METERS WERE CONNECTING AND TRANSFERRING RESULTS PROPERLY AFTER THE CHANGES WERE MADE. NO FURTHER ACTION IS RECOMMENDED AT THIS TIME. NOVA BIOMEDICAL WILL CONTINUE TO MONITOR FOR THIS OR SIMILAR EVENTS.

Description of Event or Problem

CUSTOMER IS REPORTING THAT THEY'RE SEEING DELAYS IN RESULTS BEING SENT FROM THIER NOVA STATSTRIP 1.86 CONNECTIVITY METERS TO THEIR QML MIDDLEWARE. ALTHOUGH THERE WERE NO DIRECT ALLEGATIONS OF DELAYS IN TREATMENT DUE TO THIS ISSUE, THE POTENTIAL FOR SUCH DELAYS EXISTS FOR ISSUES OF THIS NATURE.