BEUDAMED
    FDA Adverse Event Summary report: N

    ROCHE ACCUCHECK

    MDR report key: 758544 · Received November 9, 2005

    Report

    Report Number
    MW4004051
    Date Received
    November 9, 2005
    Date of Event
    December 30, 2004
    Report Date
    August 9, 2005
    Manufacturer
    *
    Product Code
    NBW
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT GOT 3 BOXES OF ACCUCHECK ACTIVE STRIPS WITH A GREEN LABEL AND THE FOLLOWING INFO: 1ST BOX, EXP = 2005-09, LOT 023/2289543; 2ND BOX, EXP = 2005-4, SAME LOT NUMBER AS BOX 1; 3RD BOX, EXP = 2005-05, SAME LOT # AS BOX #1. AS THE BOXES DID NOT HAVE THE ORANGE COLORED CALIBRATION STRIP, THEY CALLED ROCHE DIAGNOSTIC. ROCHE TOLD HIM NOT TO USE THE GLUCOSE TEST STRIPS AS THESE STRIPS WERE NOT FOR SALE IN THE UNITED STATES. EIGHT MONTHS LATER, PT PURCHASED 2 MORE BOXES OF GLUCOSE TEST STRIPS FROM ANOTHER PHARMACY. AGAIN, THESE STRIPS WERE IN A GREEN BOX, AND HE HAD BEEN TOLD BY ROCHE NOT TO USE THE PRODUCTS FROM THE GREEN BOX. BOTH BOXES HAVE THE SAME CODING INFO: EXP = 2004-12, LOT # 173/22882432.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROCHE ACCUCHECK ACTIVE, GLUCOSE TEST STRIPS NBW * * 023/2289543
    2 ROCHE ACCUCHECK ACTIVE, GLUCOSE TEST STRIPS NBW * * 023/2289543
    3 ROCHE ACCUCHECK ACTIVE, GLUCOSE TEST STRIPS NBW * * 023/2289543
    4 ROCHE ACCUCHECK ACTIVE, GLUCOSE TEST STRIPS NBW * * 173/22882432

    Patients

    Seq Age Sex Outcome Treatment
    1 *