BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STATSTRIP GLUCOSE HOSPITAL METER SYSTEM

    MDR report key: 23949611 · Received January 2, 2026

    Report

    Report Number
    1219029-2026-00001
    Event Type
    Malfunction
    Date Received
    January 2, 2026
    Date of Event
    December 10, 2025
    Report Date
    May 19, 2026
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    PZI
    UDI-DI
    00385480636858
    PMA / PMN Number
    K232075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION BEGUN BUT NOT YET COMPLETED. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41837 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