BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1110163 · Received August 14, 2008

    Report

    Report Number
    1823260-2007-05135
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    May 31, 2007
    Report Date
    June 12, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE COMPACT SYSTEM WITHIN 10 MINUTES: 172 MG/DL, 57 MG/DL, AND 88 MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO BLOOD GLUCOSE SYMPTOMS REPORTED WITH THESE RESULTS. NO QUALITY CONTROLS USED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND 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 20655441

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR CENTROID 500MG ONCE DAILY 8-9 YEARS| CARTIA 120MG ONCE DAILY - 2-3 YEARS| AVANDIA 4MG TWICE DAILY 7-8 YEARS| GLUCOPHAGE 4 500MG TABS DAILY 7-8 YEARS| BENECOL 40MG TWICE DAILY - 2-3 YEARS