BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1051716 · Received May 19, 2008

    Report

    Report Number
    1823260-2008-04119
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    May 10, 2008
    Report Date
    May 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SEE MEDWATCH WITH A1 PT FOR INFORM SYSTEM 1. THIS MEDWATCH IS BEING FILED FOR INFORM SYSTEM 2.

    Description of Event or Problem · 1

    CUSTOMER REPORTED METER RESULTS OF 31 MG/DL AND 34 MG/DL ON INFORM SYSTEM 1, 81 MG/DL ON THIS DEVICE, INFORM SYSTEM 2, AND A LAB RESULT OF 76 MG/DL WITHIN 10 MINS. CUSTOMER REPORTED NO PT SYMPTOMS, PT GIVEN "D50" BASED ON 31 MG/DL AND 34 MG/DL ON INFORM SYSTEM 1. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SYSTEM, 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. 549817

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK