BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA MAX

    MDR report key: 5249654 · Received November 19, 2015

    Report

    Report Number
    MW5058090
    Event Type
    Malfunction
    Date Received
    November 19, 2015
    Date of Event
    November 17, 2015
    Report Date
    November 19, 2015
    Manufacturer
    NOVA MAX
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT BROUGHT HIS GLUCOMETER TO OUTPATIENT PHARMACY BECAUSE OF LOW SUGAR READING THROUGHOUT THE DAY. THE PHARMACIST CONTACTED THE MANUFACTURER AND AFTER RUNNING THEIR USUAL TROUBLE SHOOTING STEPS WITH NEW CONTROL SOLUTION AND TEST STRIPS FROM THE PHARMACY, THE METER KEPT SHOWING 43 ON THE SCREEN. THE MANUFACTURING REPRESENTATIVE RECOMMENDED FOR PHARMACY TO MAIL THE GLUCOMETER TO NOVA MAX FOR FURTHER EVALUATION. THE GLUCOMETER'S SERIAL NUMBER IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766202 NOVA MAX GLUCOMETER NBW NOVA MAX

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR