BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1311207 · Received February 11, 2009

    Report

    Report Number
    1823260-2009-01092
    Event Type
    Injury
    Date Received
    February 11, 2009
    Date of Event
    January 27, 2009
    Report Date
    February 11, 2009
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S FRIEND REPORTED THAT AT 5:00 PM, THE COMPACT PLUS SYSTEM GAVE A BLOOD GLUCOSE (BG) RESULTS OF 125 MG/DL AND 23 MG/DL AT A TIME WHEN THE CUSTOMER WAS SYMPTOMATIC OF, AND WAS TREATED BY LAYPERSON FOR, HYPOGLYCEMIA. THE TIME BETWEEN THE 125 MG/DL AND 23 MG/DL WAS NOT PROVIDED. RETESTED BG WAS 67 MG/DL AN INDETERMINATE TIME AFTER TREATMENT. A REQUEST WAS MADE FOR THE RETURN OF THE SYSTEM AND 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 CORP. 20688244

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention LANTUS 30 UNITS/PM - 2 YEARS| LANTUS 50 UNITS/AM - 2 YEARS| HUMALOG SLIDING SCALE - 5 YEARS