BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION PRIME BLOOD GLUCOSE SYSTEM

    MDR report key: 2992661 · Received March 7, 2013

    Report

    Report Number
    1832816-2013-00017
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    ARKRAY, INC.
    Product Code
    CGA
    PMA / PMN Number
    K091102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVOLVED IN INCIDENT WAS RETURNED AND EVALUATED. THE RETURNED PRODUCT GAVE 'LO' RESULTS CONFIRMING THE COMPLAINT. RETENTION SAMPLES OF THE SAME LOT OF TEST STRIPS INVOLVED IN THE INCIDENT WERE TESTED AND PERFORMED TO SPECIFICATION. MANUFACTURER IS AWARE OF THE ISSUE WHICH IS UNDER INVESTIGATION (CAPA (B)(4)).

    Description of Event or Problem · 1

    CALLER INDICATED THE RELION PRIME WAS GIVING LOW READINGS. CALLER STATED SHE WAS CONTINUALLY GETTING THE 'LO' READING, SHE COMPLETED A TEST ON THE PHONE AND HAS PROPER TECNHIQUE. SHE KNOWS SHE'S NOT UNDER 20MG AND FEELS THERE IS SOMETHING WRONG WITH THE METER. REPLACED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97795 RELION PRIME BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM CGA ARKRAY, INC. 701103 11162B

    Patients

    Seq Age Sex Outcome Treatment
    1