BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1032702 · Received April 22, 2008

    Report

    Report Number
    1823260-2008-03438
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    April 15, 2008
    Report Date
    April 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTS BACK TO BACK TESTING ON THE SAME METER WHILE USING THE COMPACT PLUS SYSTEM WITH RESULTS OF 82MG/DL AND 207MG/DL. 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 STRIPS - LFR LFR ROCHE DIAGNOSTICS 20663341

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR LANTUS 12 UNITS 2XDAY 4 YRS| ACTOS 45MG/DAY 3 YRS| CARBLEVO 25/100MG 4XDAY 10 YRS| EPHETSER 75MG/DAY - UNK| LIPITOR 10MG/DAY - UNK| SYNTHROID 150MCG/DAY - FEW YRS| MERIPAT 1.5MG 3X/DAY - UNK| DESICARE 10MG/DAY - UNK