BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1041201 · Received May 9, 2008

    Report

    Report Number
    1823260-2008-03890
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 6, 2008
    Report Date
    May 9, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORM SYSTEM 2 DOCUMENTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED BLOOD GLUCOSE RESULTS OF " 300'S" MG/DL WITH INFORM SYSTEM 1 AND "100'S" MG/DL WITH INFORM SYSTEM 2 WERE PERFORMED WITHIN 10 MINS. CUSTOMER REPORTED NO PT SYMPTOMS AND DID NOT TREAT OR ACT ON RESULTS. NO SERIOUS ADVERSE EVENT WAS REPORTED IN CONNECTION WITH THE ALLEGED MALFUNCTION. 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 COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK