BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GLUCOSE METER

    MDR report key: 1052387 · Received May 23, 2008

    Report

    Report Number
    1826988-2008-00549
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    April 27, 2008
    Report Date
    April 27, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED FOR HELP WITH HER METER. WHILE TROUBLESHOOTING, SHE PERFORMED CONTROL TESTS AND REC'D A RESULT OF 247 MG/DL. THE NORMAL CONTROL RANGE WAS 100-138 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS ARE TO BE RETURNED FOR EVAL. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOOD GLUCOSE METER NBW BAYER HEALTHCARE, LLC 7080D 7LC3A03

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK