BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA BIOMEDICAL STAT STRIP

    MDR report key: 20155598 · Received September 6, 2024

    Report

    Report Number
    20155598
    Event Type
    Malfunction
    Date Received
    September 6, 2024
    Date of Event
    April 4, 2024
    Report Date
    May 29, 2024
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    PZI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    GLUCOMETER WITH MULTIPLE CRITICAL LOW READINGS TRIGGERING PATIENT TO GET D10 BOLUS TO INCREASE GLUCOSE LEVELS. WHEN BLOOD SENT TO THE LAB AT THE SAME TIME, WITH NORMAL GLUCOSE LEVELS. SUSPECT GLUCOMETER ERROR AS PATIENT'S BLOOD GLUCOSE LEVELS HAVE BEEN NORMAL SINCE SENDING ALL BLOOD TO THE LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2035988 NOVA BIOMEDICAL STAT STRIP GLUCOSE TEST SYSTEM. PZI NOVA BIOMEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown