BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1011473 · Received March 11, 2008

    Report

    Report Number
    1823260-2008-02298
    Event Type
    Injury
    Date Received
    March 11, 2008
    Date of Event
    February 15, 2008
    Report Date
    March 11, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS HE TOOK HIS BLOOD GLUCOSE WITH A RESULT OF 215 MG/DL WHILE USING THE COMPACT SYSTEM. CUSTOMER STATES HE TOOK HIS NORMAL DOSE OF HUMALOG AND ATE BREAKFAST. CUSTOMER REPORTS 2 MINUTES LATER HE PASSED OUT AND WAS FOUND BY HIS WIFE WHO CALLED THE PARAMEDICS. CUSTOMER STATES PARAMEDICS TOOK HIS BLOOD GLUCOSE WITH A RESULT OF 24MG/DL AND TREATED HIM WITH AN IV OF UNK CONTENT AND PLACED SOMETHING AROUND HIS HEAD AND IN HIS NOSE. CUSTOMER REPORTS HE LEFT THE CAP OFF OF A NEW DRUM CONTAINER FOR 2 OR 3 DAYS PRIOR TO USING ALL THE STRIPS IN THE EXISTING DRUM. NO CONTROLS WERE RUN. CUSTOMER NO LONGER HAS STRIPS USED AT THE TIME OF THE EVENT; A 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention HUMALOG SLIDING SCALE 1.5 YRS