BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1040990 · Received May 8, 2008

    Report

    Report Number
    1823260-2008-03853
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    May 3, 2008
    Report Date
    May 8, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED METER RESULTS OF 330 MG/DL AND 153 MG/DL WITHIN 10 MINUTES ON THE COMPACT PLUS SYSTEM; ALSO 238 MG/DL AND 543 MG/DL WITHIN 10 MINUTES, 226 MG/DL WITHIN 10 MINUTES OF 543 MG/DL. CUSTOMER REPORTED NO SYMPTOMS, DID NOT TREAT OR ACT ON RESULTS. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SYS, 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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR DYRENIUM - 200MG/DAY| ZYLOPRIM - 600MG/DAY| PEPCID - 40MG/DAY| HUMALOG SLIDING SCALE| LANTUS - 200 UNITS/DAY| CLARITIN - 10MG/DAY| SINGULAIR - 10MG/DAY| ZAROXOLYN - 7.5MG/DAY| KADIAN - 700MG/DAY| ASPIRIN - 80MG/DAY| POTASSIUM CHLORIDE - 70MG/DAY| LASIX - 240MG/DAY