BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION PRIME BLOOD GLUCOSE SYSTEM

    MDR report key: 2962121 · Received February 14, 2013

    Report

    Report Number
    1832816-2013-00010
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 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. PRODUCT HAS BEEN FORWARDED TO THE MANUFACTURER TO BE INVESTIGATED (CAPA (B)(4)).

    Description of Event or Problem · 1

    CALLER INDICATED THE RELION PRIME STRIPS WERE GIVING LOW READINGS. CALLER STATED THEY WERE GETTING A READING OF 'LO' ALL THE TIME. TRIED TEST MULTIPLE TIMES AND GET SAME RESULTS. HAS NO PHYSICAL SYMPTOMS OF LOW BLOOD SUGAR. THOUGHT METER WAS PROBABLY BAD SO BOUGHT A NEW METER AND STILL GETTING 'LO' ALL THE TIME. TRIED METER ON OTHER PEOPLE AND GOT 'LO' READING STILL. HE WAS USING THE METER BEFORE AND GETTING GOOD READINGS. JUST STARTED READING 'LO' WHEN HE BOUGHT NEW BOTTLE OF STRIPS. REPLACED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65206 RELION PRIME BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM CGA ARKRAY, INC. 700050 11162B

    Patients

    Seq Age Sex Outcome Treatment
    1