BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSURE PLATINUM BLOOD GLUCOSE SYSTEM

    MDR report key: 3851847 · Received June 5, 2014

    Report

    Report Number
    1832816-2014-00047
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 11, 2014
    Report Date
    June 5, 2014
    Manufacturer
    ARKRAY, INC.
    Product Code
    NBW
    PMA / PMN Number
    K092104
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS WERE REVIEWED AND NO ANOMALIES WERE DETECTED. 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 ASSURE PLATINUM METER WAS PRODUCING VARIABLE READINGS. THE NURSE CHECKED THE PATIENT'S BLOOD SUGAR USING FOUR DIFFERENT METERS. SHE RECEIVED READINGS OF HI, 45, 123, 156, 69 USING TWO METERS AND THEN 10 MINUTES LATER SHE TESTED WITH TWO OTHER METERS AND RECEIVED 42 AND 43 WHICH MATCHED HER SYMPTOMS. SHE WAS PALE, COOL, AND CLAMMY AND STARTED SWEATING AFTER THE 5TH TEST. THE CALLER FEELS THE FIRST TWO METERS USED WHERE NOT ACCURATE DUE TO THE FLUCTUATION IN READINGS. THEY ARE USING THE CORRECT TESTING TECHNIQUE FOR EACH TEST. THEY CLEANED THE PATIENT'S FINGERTIP WITH ALCOHOL MAKING SURE THAT IT WAS DRY BEFORE POKING. THE PATIENT IS NOT ON OXYGEN THERAPY AND HAS NO CHANGES IN MEDICATION OR STRESS. THE PATIENT WAS NOT TREATED BASED ON METER READINGS BUT WAS TREATED FOR LOW BLOOD SUGAR BECAUSE OF HER SYMPTOMS. CONTROLS USED WERE IN RANGE. REPLACING PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329174 ASSURE PLATINUM BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM NBW ARKRAY, INC. 500001 04074C

    Patients

    Seq Age Sex Outcome Treatment
    1