BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELION MICRO BLOOD GLUCOSE SYSTEM

    MDR report key: 2111900 · Received June 2, 2011

    Report

    Report Number
    1832816-2011-00030
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 5, 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

    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 READING HIGH. CALLER STATED THAT AT 6:52 AM SHE TOOK HER BGL AND HER RESULT WAS 285 SHE FELT THAT THE READING WAS HIGH, WHICH PROMPTED HER TO TAKE ANOTHER TEST. AT 7:03 AM SHE RETESTED, RELANCED HER FINGER GOT A NEW DROP OF BLOOD AND HER BGL RESULT WAS HI (OVER 600 MG/DL) THIS PROMPTED CALLER TO CONTACT US. CALLER DOES NOT HAVE CONTROL SOLUTION TO TEST THE METER. CALLER IS UNSURE OF WHAT SYMPTOMS TO WATCH FOR, UNSURE OF WHAT READINGS ARE TOO HIGH/LOW. I HAVE SUGGESTED THAT SHE CONTACT HER HEALTH CARE TEAM TO GET MORE INFORMATION. CALLER RECENTLY HAD SURGERY AND STATED THAT SHE DOESN'T SEEM TO HAVE ANY SYMPTOMS UNRELATED TO HER SURGERY, SHE IS TIRED AND THIRSTY. NO TREATMENT GIVEN. 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 A115A10

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening