BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STATSTRIP GLUCOSE HOSPITAL METER SYSTEM

    MDR report key: 24967156 · Received April 23, 2026

    Report

    Report Number
    1219029-2026-00028
    Event Type
    Malfunction
    Date Received
    April 23, 2026
    Date of Event
    March 26, 2026
    Report Date
    April 23, 2026
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    PZI
    UDI-DI
    00385480636858
    PMA / PMN Number
    K232075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION INTO THE ROOT CAUSE OF THE REPORTED ISSUE HAS BEGUN BUT IS NOT YET COMPLETED. A SUPPLEMENTAL REPORT WILL BE ISSUED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    PER CUSTOMER "REPLACEMENT METERS RECENTLY RECEIVED ARE LOSING CONNECTION TO THE NETWORK AND SERVER AND ATTEMPTING TO CONNECT TO THE HOSPITAL GUEST WIFI. THIS IS CAUSING A SIGNIFICANT DELAY IN RESULTS REACHING THE CHART AND IMPACTING PATIENT CARE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028436 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