BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1162187 · Received September 16, 2008

    Report

    Report Number
    1823260-2008-06914
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    September 6, 2008
    Report Date
    September 16, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED SHE TREATED HERSELF WITH 18 UNITS OF INSULIN 70/30 BASED UPON A COMPACT SYSTEM BLOOD GLUCOSE RESULT OF 363 MG/DL, THEN HAD RESULTS OF 118 MG/DL AND 87 MG/DL WITHIN 10 MINUTES ON THE SAME SYSTEM. CUSTOMER REPORTED NO SYMPTOMS, NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SYSTEM, 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 20680441

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR PENTOXIFYLLINE 1200 MG/DAY - 1 YEAR| "LIBERAX" 5MG/DAY - "LONG TIME"| GLIPIZIDE 10 MG/DAY - "YEARS"| FUROSEMIDE 40 MG/DAY - "QUITE A WHILE"| INSULIN 70/30 SLIDING SCALE - "MANY YEARS"| BABY ASPIRIN 81 MG/DAY - 3-4 MONTHS| SIMVASTATIN 80 MG/DAY| "CHOLTRON" 10 MG/DAY