BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELION MICRO BLOOD GLUCOSE SYSTEM

    MDR report key: 2132280 · Received June 17, 2011

    Report

    Report Number
    1832816-2011-00041
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    ARKRAY, INC.
    Product Code
    CGA
    PMA / PMN Number
    K073416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVOLVED IN INCIDENT WAS RETURNED AND EVALUATED. THE RETURNED PRODUCT PERFORMED WITHIN SPECIFICATION. RETENTION SAMPLES OF THE SAME LOT OF TEST STRIPS INVOLVED IN THE INCIDENT WERE ALSO TESTED AND PERFORMED TO SPECIFICATION. NO FAILURE DETECTED.

    Description of Event or Problem · 1

    CALLER INDICATED THE RELION MICRO METER WAS GIVING HIGH READINGS. CALLER TESTED BG FIRST THING THIS MORNING AND SHE RCVD A READING OF HI. SHE IMMEDIATELY TOOK HUMALOG. AND 6 OZ OF ORANGE JUICE. SHE WASN'T FEELING SYMPTOMS SO ABOUT 15 MINUTES AFTER GETTING HI AND DOSING, SHE RETESTED 5X AND GOT THE FOLLOWING READINGS 299, 203, 312, 313,330. WHILE ON THE PHONE WITH ME (ABOUT AN HOUR AFTER THE INCIDENT HER READING WAS 380) CALLER STATED THAT HER READINGS ARE USUALLY ALL OVER, BUT MORE SO SINCE SHE STARTED USING THIS METER. CONTROLS NOT USED. 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 A115A11

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening