BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAYERS HEALTH CARE A1CNOW SELFCHECK

    MDR report key: 2654755 · Received July 9, 2012

    Report

    Report Number
    MW5026125
    Event Type
    Malfunction
    Date Received
    July 9, 2012
    Date of Event
    July 6, 2012
    Report Date
    July 9, 2012
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    LCP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I BOUGHT A1CNOW SELFCHECK KIT, LOT NUMBER: 1129725, EXPIRING ON 08/01/2013, DISTRIBUTED BY (B)(4) ¿ ON (B)(6) 2012, FROM (B)(6), FOR MY DAD. IT CONTAINED 2 TEST KITS FOR A1C BLOOD TESTS. DEVICE GAVE ME ERROR MESSAGE, THOUGH I FOLLOWED THE EXACT WRITTEN INSTRUCTIONS FOR OPERATION. I DECIDED TO USE THE 2ND KIT AS I NEEDED TO SEE BLOOD GLUCOSE LEVEL FOR MY DAD. THE SECOND KIT GAVE ME THE ERROR MESSAGE. AGAIN, THIS TIME, I FOLLOWED THE INSTRUCTIONS. DATE OF USE: (B)(6) 2012. REASON FOR USE: ERROR MESSAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAYERS HEALTH CARE A1CNOW SELFCHECK A1CNOW SELFCHECK LCP BAYER HEALTHCARE LLC 1129725

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR