BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURE PLATINUM BLOOD GLUCOSE SYSTEM

    MDR report key: 1930630 · Received December 16, 2010

    Report

    Report Number
    1832816-2010-00034
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 2, 2010
    Manufacturer
    ARKRAY, INC.
    Product Code
    CGA
    PMA / PMN Number
    K092104
    Product Problem
    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. THE RETURNED PRODUCT PERFORMED WITHIN SPECIFICATION. NO FAILURE DETECTED.

    Description of Event or Problem · 1

    CALLER INDICATED THE ASSURE PLATINUM METER WAS GIVING VARIABLE READINGS. THE NURSE TESTED THE PATIENT AND RECEIVED A RESULT OF 473 AFTER FOLLOWING THE PROPER TESTING TECHNIQUE. PATIENT FELT FINE, BUT FELT THAT WAS TOO HIGH OF A READING AND ASKED TO BE RETESTED. THE NURSE RETESTED THE PATIENT ON THE SAME METER WITH THE SAME STRIPS FOLLOWING THE PROPER TESTING TECHNIQUE BACK TO BACK FROM RECEIVING THE 473 RESULT AND RECEIVED 139. THE PATIENT IS FINE AT THE FACILITY, NO MEDICAL INTERVENTION NEEDED. CONTROLS IN RANGE.

    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 09200A

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR