BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION MICRO BLOOD GLUCOSE SYSTEM

    MDR report key: 2119527 · Received June 10, 2011

    Report

    Report Number
    1832816-2011-00035
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 2011
    Manufacturer
    ARKRAY, INC.
    Product Code
    CGA
    PMA / PMN Number
    K073416
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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.

    Description of Event or Problem · 1

    CALLER INDICATED THE RELION MICRO METER WAS GIVING VARIABLE READINGS. FROM 12:03 TO 12:13 GOT READINGS OF 36, 230, 239, 270, 229, 220 - DOES NOT HAVE CONTROL SOLUTION. NO SYMPTOMS. REPLACED PRODUCT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELION MICRO BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM CGA ARKRAY, INC. 710050 A115A16

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR