BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1000416 · Received February 20, 2008

    Report

    Report Number
    1823260-2008-01707
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    February 13, 2008
    Report Date
    February 20, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER STATES, THE PATIENT TESTED 238MG/DL ON THE INFORM SYSTEM AT 3:00AM AND EXHIBITED HYPOGLYCEMIC SYMPTOMS. A LAB WAS DRAWN AT 3:36AM AND RETURNED AS <20MG/DL. CUSTOMER WAS GIVEN GLUCOSE IN SOME FORM AS TREATMENT BASED ON LAB RESULT. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT 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 549713

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention