BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STATSTRIP GLUCOSE HOSPITAL METER SYSTEM

    MDR report key: 24316751 · Received February 11, 2026

    Report

    Report Number
    1219029-2026-00012
    Event Type
    Malfunction
    Date Received
    February 11, 2026
    Date of Event
    January 16, 2026
    Report Date
    February 11, 2026
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    PZI
    UDI-DI
    00385480547901
    PMA / PMN Number
    K150281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379678 STATSTRIP GLUCOSE HOSPITAL METER SYSTEM PRESCRIPTION USE BLOOD GLUCOSE METER FOR NEAR-PATIENT TESTING PZI NOVA BIOMEDICAL CORP. 1.86 00385480547901

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown