BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1053176 · Received May 27, 2008

    Report

    Report Number
    1823260-2008-04320
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 27, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE COMPACT PLUS SYSTEM WITHIN 10 MINUTES: 532 MG/DL, 282 MG/DL, AND 230 MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. 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 20675241

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR LEVOTHYROXINE 100MCG/DAY - 10 YEARS| NOVOLIN N 35UNITS PM - 25 YEARS| LASIX 60MG/DAY - 10 YEARS| LANOXIN 0.25MG/DAY - 10 YEARS| NOVOLIN N 55UNITS AM - 25 YEARS| PACERONE 200MG/DAY - 10 YEARS| K-DUR 10MEQ/DAY - 10 YEARS