BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELION MICRO BLOOD GLUCOSE SYSTEM

    MDR report key: 2488421 · Received March 12, 2012

    Report

    Report Number
    1832816-2012-00018
    Event Type
    Injury
    Date Received
    March 12, 2012
    Date of Event
    February 21, 2012
    Report Date
    February 21, 2012
    Manufacturer
    ARKRAY, INC.
    Product Code
    NBW
    PMA / PMN Number
    K082417
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVOLVED IN INCIDENT WAS RETURNED AND EVALUATED. THE RETURNED PRODUCT PERFORMED WITHIN SPECIFICATION. NO FAILURE DETECTED.

    Description of Event or Problem · 1

    CALLER INDICATED THE RELION MICRO WAS GIVING INACCURATE RESULTS WHICH CAUSED HIM TO TAKE 5 MG OF GEMFIBROZIL. HE GOT READINGS OF 253, 213, 109, 223 AND 217 ALL WITHIN 10 MINUTES FROM THE SAME PUNCTURE WHICH CAUSED HIM TO TAKE 5 MG OF GEMFIBROZIL. HE DOESN'T TRUST THAT THE METER IS READING CORRECTLY. HE DOESN'T HAVE CONTROL SOLUTION TO TEST THE METER. REPLACING PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELION MICRO BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM NBW ARKRAY, INC. 712001 L115A04

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Life Threatening