BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1162188 · Received September 16, 2008

    Report

    Report Number
    1823260-2008-06915
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    September 8, 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
    CO, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S HUSBAND REPORTED BLOOD GLUCOSE RESULTS OF 111 MG/DL AND 242 MG/DL WITHIN 10 MINUTES ON THE COMPACT SYSTEM. CUSTOMER REPORTED NO SYMPTOMS, DID NOT TREAT OR ACT ON RESULTS. 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 20682341

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR METOPROLOL 50MG/DAY - "YEARS"| PANTOPRAZOLE 40 MG/DAY - "YEARS"| AMLODIPINE 2.5 MG/DAY - "YEARS"| PLAVIX 75 MG/DAY - "YEARS"| ZETIA 10 MG/DAY - "YEARS"| AVAPRO 300 MG/DAY "YEARS"| ASPIRIN 81 MG/DAY - "YEARS"| NITROFURAN 40 MG/DAY - "YEARS"| LIPITOR 20 MG/DAY - "YEARS"| METFORMIN 500 MG/DAY - 2 YEARS