BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION CONFIRM BLOOD GLUCOSE SYSTEM

    MDR report key: 2132167 · Received June 17, 2011

    Report

    Report Number
    1832816-2011-00039
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 20, 2011
    Manufacturer
    ARKRAY, INC.
    Product Code
    CGA
    PMA / PMN Number
    K073416
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL PRODUCT WAS NOT RETURNED FOR TESTING. RETENTION SAMPLES OF THE SAME LOT OF TEST STRIPS INVOLVED IN THE INCIDENT WERE TESTED AND PERFORMED TO SPECIFICATION. CUSTOMER DID NOT RETURN PRODUCT.

    Additional Manufacturer Narrative · 1

    PRODUCT INVOLVED IN INCIDENT WAS RETURNED, BUT THE TEST STRIPS WERE EXPIRED. THE RETURNED METER WAS EVALUATED WITH REFERENCE TEST STRIPS AND PERFORMED TO SPECIFICATION. NO FAILURE DETECTED.

    Description of Event or Problem · 1

    CALLER INDICATED THE RELION CONFIRM METER WAS GIVING VARIABLE READINGS. READINGS OF 38, 338, 230 WITHIN 10 MINS OF EACH OTHER. NO CHANGE IN DIET. USING SAME LANCET WITH EVERY POKE. CONTROLS NOT USED. REPLACING PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELION CONFIRM BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM CGA ARKRAY, INC. 710050 J105A15

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR