BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 992708 · Received February 6, 2008

    Report

    Report Number
    1823260-2008-01275
    Event Type
    Malfunction
    Date Received
    February 6, 2008
    Date of Event
    January 1, 2007
    Report Date
    February 6, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED IN, "ACCURACY OF BEDSIDE CAPILLARY BLOOD GLUCOSE MEASUREMENTS IN CRITICALLY ILL PATIENTS" IN INTENSIVE CARE MED (2007) 33:2079-2084.

    Description of Event or Problem · 1

    JOURNAL ARTICLE REPORTED DISCREPANT BLOOD GLUCOSE VALUES OBTAINED FROM THE INFORM SYSTEM WHEN COMPARED WITH LABORATORY TESTS WHEN TESTING WAS PERFORMED BACK-TO-BACK. NO SPECIFIC DATA WERE REPORTED. THE ARTICLE DID NOT REPORT ANY ADVERSE EVENTS AS A RESULT OF THE DISCREPANT VALUES. SINCE THE DISCREPANT RESULTS WERE NOT REPORTED TO THE MANUFACTURER AT THE TIME THE STUDY WAS PERFORMED, NO REQUEST COULD BE MADE FOR RETURN OF THE SUSPECT DEVICE.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK NOREPINEPHRINE / 25% OF PATIENTS| INSULIN / UNK% OF PATIENTS| STEROIDS / 20% OF PATIENTS