BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1060079 · Received June 12, 2008

    Report

    Report Number
    1823260-2008-04692
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    June 9, 2008
    Report Date
    June 12, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER REPORTS BACK TO BACK COMPARISON TO THE LAB WHILE USING THE COMPACT PLUS SYSTEM WITH RESULTS OF 124MG/DL ON THE METER AND 66MG/DL AT THE LAB. NO QUALITY CONTROLS WERE RUN. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT AND A REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIP - LFR LFR ROCHE DIAGNOSTICS 20678541

    Patients

    Seq Age Sex Outcome Treatment
    1 15 MO OMEPRAZOLE 10ML/DAY - 1 WEEK| PHENOBARBITAL 35ML/DAY - 2 MONTHS| ZANTAC 3CC/DAY IN IV - 6 MONTHS| KEPPRA 1.8ML 2X/DAY - 2 MONTHS| ZOFRAN 1.25ML EVERY 8HRS AS NEEDED - 6 MONTHS| VANCOMYCIN 5ML 2X/DAY - 1 WEEK| CLONIDINE 0.4 ML EVERY 8 HOURS - 6 MONTHS| BENADRYL 2.5ML EVERY 6HRS AS NEEDED - 4 MONTHS