BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1344262 · Received March 13, 2009

    Report

    Report Number
    1823260-2009-02008
    Event Type
    Injury
    Date Received
    March 13, 2009
    Date of Event
    February 19, 2009
    Report Date
    March 13, 2009
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINED A 396 MG/DL RESULT ON THE ADVANTAGE WHILE FEELING SWEATY AND INCOHERENT. REPORTER STATED THAT HIS SON TREATED HIM WITH TWO GLUCOSE TABLETS AND A PACK OF HONEY. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention