BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 2171720 · Received July 22, 2011

    Report

    Report Number
    1823260-2011-03896
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 27, 2011
    Report Date
    July 20, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTED TAKING 40 UNITS OF NOVOLOG INSULIN BASED UPON A COMPACT PLUS SYSTEM BLOOD GLUCOSE RESULT OF 487 MG/DL. RETEST RESULTS WITHIN 10 MINUTES WERE 41 MG/DL AND 38 MG/DL. CUSTOMER REPORTED NO SYMPTOMS, BUT SELF-TREATED BY DRINKING ORANGE JUICE AND SUGAR WATER AND EATING HONEY. CUSTOMER CALLED 911. PARAMEDICS' SYSTEM RESULT MORE THAN 10 MINUTES LATER WAS 67 MG/DL. THEY DID NOT TREAT, STAYED UNTIL 30 MINUTES HAD PASSED FROM WHEN THE CUSTOMER TOOK NOVOLOG AND HIS BLOOD GLUCOSE RESULT WAS 95 MG/DL ON THEIR METER. REPORTED NO ADVERSE EVENT. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 20729743

    Patients

    Seq Age Sex Outcome Treatment
    1 072 YR "LONG ACTING INSULIN"| NOVOLOG