BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STATSTRIP GLUCOSE HOSPITAL METER SYSTEM

    MDR report key: 24474747 · Received February 27, 2026

    Report

    Report Number
    1219029-2026-00013
    Event Type
    Malfunction
    Date Received
    February 27, 2026
    Date of Event
    January 29, 2026
    Report Date
    February 27, 2026
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    PZI
    UDI-DI
    00385480636858
    PMA / PMN Number
    K232075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TECHNICAL SUPPORT WAS ABLE TO MANUALLY MARK THE UNTRANSMITTED RESULTS AS TRANSMITTED WHICH ALLOWED THE RESULTS TO START FLOWING TO THE PATIENTS CHARTS. AN INVESTIGATION INTO THE ROOT CAUSE OF THIS ISSUE HAS BEGUN BUT IS NOT YET COMPLETED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THOUSANDS OF DUPLICATE RESULTS WERE SENT FROM THE SAME NOVA STATSTRIP GLUCOSE METER. THESE RESULTS "CLOGGED" UP THEIR LIS FEED INTO QML (MIDDLEWARE). THIS PREVENTED OTHER RESULTS FROM ENTERING THE PATIENT CHARTS. ALTHOUGH THERE WAS NO SPECIFIC ALLEGATIONS OF DELAYS IN TREATMENT DUE TO THIS OCCURRENCE, THIS ISSUE COULD LEAD TO POTENTIAL DELAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537296 STATSTRIP GLUCOSE HOSPITAL METER SYSTEM PRESCRIPTION USE BLOOD GLUCOSE METER FOR NEAR-PATIENT TESTING PZI NOVA BIOMEDICAL CORP. 2.0 00385480636858

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown