BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STATSTRIP GLUCOSE HOSPITAL METER SYSTEM

    MDR report key: 24222320 · Received January 30, 2026

    Report

    Report Number
    1219029-2026-00008
    Event Type
    Malfunction
    Date Received
    January 30, 2026
    Date of Event
    January 3, 2026
    Report Date
    May 20, 2026
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    PZI
    PMA / PMN Number
    K232075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 INVESTIGATION.

    Description of Event or Problem · 0

    STATSTRIP METER SENDING A BLANK NTE SEGMENT TO CUSTOMER'S CONNECTIVITY SOFTWARE (RALS). THIS CAUSED THE RESULT TO NOT TRANSMIT TO RALS AND PREVENTED OTHER RESULTS BEHIND THIS ONE TO ALSO NOT TRANSFER TO THE PATIENTS CHART. ALTHOUGH NO SPECIFIC ALLEGATIONS WERE MADE REGARDING DELAYS IN TREATMENT, THIS ISSUE COULD HAVE LED TO POTENTIAL DELAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85781 STATSTRIP GLUCOSE HOSPITAL METER SYSTEM PRESCRIPTION USE BLOOD GLUCOSE METER FOR NEAR-PATIENT TESTING PZI NOVA BIOMEDICAL CORP. 2.0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown