BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1761324 · Received July 20, 2007

    Report

    Report Number
    1823260-2007-06363
    Event Type
    Malfunction
    Date Received
    July 20, 2007
    Date of Event
    July 5, 2007
    Report Date
    July 20, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 1. (B)(4).

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A PATIENT RESULT OF 578 MG/DL ON INFORM SYSTEM 1 COMPARED TO A RESULT OF 240 MG/DL ON INFORM SYSTEM 2 WHEN TESTING WAS PERFORMED BACK TO BACK WITHIN 8 MINUTES APART. REPORTER INDICATING ORDERING A LAB MEASUREMENT TO BE PERFORMED HOWEVER WAS NOT SURE OF WHAT, IF ANY, TREATMENT WAS PROVIDED TO THE PATIENT. NO OTHER ACTIONS OR TREATMENT WAS REPORTED. 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 549633

    Patients

    Seq Age Sex Outcome Treatment
    1 NA