BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1341671 · Received March 10, 2009

    Report

    Report Number
    1823260-2009-01896
    Event Type
    Injury
    Date Received
    March 10, 2009
    Date of Event
    March 6, 2009
    Report Date
    March 10, 2009
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED LOW BLOOD GLUCOSE SYMPTOMS WITH BLOOD GLUCOSE RESULT OF 231 MG/DL OBTAINED ON THE COMPACT PLUS SYSTEM. CUSTOMER'S SPOUSE TREATED HER WITH SUGAR PACKETS AND SPRITE; CUSTOMER'S LOW BLOOD GLUCOSE SYMPTOMS IMPROVED. 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 CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention NPH: 7 UNITS AM/3 UNITS PM| HUMALOG: 3 UNITS 3/DAY