BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELION MICRO BLOOD GLUCOSE SYSTEM

    MDR report key: 1930417 · Received December 16, 2010

    Report

    Report Number
    1832816-2010-00032
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 13, 2010
    Report Date
    November 21, 2010
    Manufacturer
    ARKRAY, INC.
    Product Code
    CGA
    PMA / PMN Number
    K073416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 LOW. CALLER TOOK PATIENTS BG READING AND THE READING WAS 135, WITHIN ONE MINUTE, NEW BLOOD DROP READING WAS 100, WITHIN 3 MINUTES THE READING DROPPED ANOTHER 10-15 POINTS. CALLER THEN TOOK HER TO THE EMERGENCY ROOM BASED ON THE READINGS DROPPING SO QUICKLY. WHEN ARRIVED AT ER THE DOCTOR CHECKED HER BLOOD SUGAR AND THE READING WAS 215. CONTROLS NOT USED.

    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 E105A08

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization