BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA MAX LANCING DEVICE

    MDR report key: 4604010 · Received March 5, 2015

    Report

    Report Number
    MW5041406
    Event Type
    Malfunction
    Date Received
    March 5, 2015
    Date of Event
    March 5, 2015
    Report Date
    March 5, 2015
    Manufacturer
    NOVA MAX
    Product Code
    FMK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THERE WAS NO PATIENT REACHED. THE PRODUCT WAS USED DURING DIABETIC TRAINING CLASS. PARTICIPANTS HAD PREPARED LANCING DEVICES, SPRUNG THEM BACK AND DISCOVERED THEY ARE BROKEN - LANCET EXTENDS OUT THROUGH LANCING DEVICE CAP. ANOTHER LANCING DEVICE CAP WAS CRACKED ON THE SIDE AND UNABLE TO BE USED. DAMAGED. PATIENTS NOTICED. LANCING DEVICE WAS REMOVED AND A NEW ONE PROVIDED FOR PATIENT TRAINING. LANCING DEVICES OF GLUCOMETERS: NOVA MAX PLUS GLUCOMETER SERIAL # (B)(4) - BROKEN LANCING DEVICES WITH LANCET PROTRUDING BEYOND CAP. NOVA MAX PLUS GLUCOMETER SERIAL # (B)(4) LANCING DEVICE CAP IS CRACKED AND DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152680 NOVA MAX LANCING DEVICE LANCET FMK NOVA MAX
    152681 NOVA MAX LANCING DEVICE LANCET FMK NOVA MAX
    152682 NOVA MAX LANCING DEVICE LANCET FMK NOVA MAX

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA