BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASSURE PLATINUM BLOOD GLUCOSE SYSTEM

    MDR report key: 1930626 · Received December 16, 2010

    Report

    Report Number
    1832816-2010-00033
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 29, 2010
    Manufacturer
    ARKRAY, INC.
    Product Code
    CGA
    PMA / PMN Number
    K092104
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVOLVED IN INCIDENT WAS RETURNED AND EVALUATED. A SMALL PIECE OF THE METER CASING WAS MISSING FROM USER DAMAGE, BUT THE RETURNED PRODUCT PERFORMED WITHIN SPECIFICATION. NO FAILURE DETECTED.

    Description of Event or Problem · 1

    CALLER INDICATED THE ASSURE PLATINUM METER WAS READING HIGH. AFTER LUNCH PT WAS VERY SYMPTOMATIC, CALLER TESTED BG AND THE READING CAME BACK AS 110MG/DL, SHE RETESTED WITH A DIFFERENT METER AND THE BG READING CAME BACK AS 43MG/DL. HAILEY GAVE ORANGE JUICE AND TOAST AS TREATMENT AND PT IS CURRENTLY FEELING BETTER. REPLACING METER AND STRIPS. CONTROLS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASSURE PLATINUM BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM CGA ARKRAY, INC. 500050 06250A

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention