BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1220478 · Received November 4, 2008

    Report

    Report Number
    1823260-2008-08148
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    September 18, 2008
    Report Date
    November 4, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT SHE WOKE UP AND TOOK A SHOWER. SHE ALSO OBTAINED THE BLOOD GLUCOSE RESULTS OF 199-250MG/DL ON THE ACCU-CHEK COMPACT SYSTEM. THE CUSTOMER DOSED HERSELF WITH INSULIN BASED ON THE 199-250MG/DL BLOOD GLUCOSE RESULT. ABOUT THIRTY MINUTES LATER, THE CUSTOMER "BLACKED OUT". THE EMERGENCY MEDICAL TECHNICIANS TREATED HER WITH INTRAVENOUS THERAPY AND TRANSPORTED HER TO THE HOSPITAL. THE CUSTOMER'S BLOOD GLUCOSE RESULTS WERE 620MG/DL AND 580MG/DL ON THE PROFESSIONAL METER. THE CUSTOMER RECEIVED INSULIN THERAPY. THE CUSTOMER DISCARDED THE METER AND STRIP VIAL. THE SUSPECTED PRODUCT IS UNAVAILABLE FOR RETURN; 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 54 YR Required Intervention INSULIN (UNK TYPE)| "METQUIZINE"- 10 YEARS| METFORMIN| "CERIQUILL" 10 YEARS| PLAVIX 4 YEARS| GLUCOPHAGE| LEXIPRO 5 YEARS