BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASSURE PLATINUM BLOOD GLUCOSE SYSTEM

    MDR report key: 1834231 · Received September 14, 2010

    Report

    Report Number
    1832816-2010-00019
    Event Type
    Injury
    Date Received
    September 14, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 24, 2010
    Manufacturer
    ARKRAY FACTORY USA, INC.
    Product Code
    NBW
    PMA / PMN Number
    K092104
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 WAS GIVING INACCURATE READINGS. THE PATIENT WAS SWEATING PROFUSELY AND SHOWED AN ALTERED MENTAL STATE. THE ASSURE PLATINUM WAS USED TO TAKE HIS BLOOD GLUCOSE READING AND IT SHOWED 206, A NORMAL LEVEL. THE PATIENT WAS FEELING SO ILL THAT THE NURSE EVENTUALLY CALLED AN AMBULANCE, IN THE PARKING LOT HE TESTED 30 AND WAS ALMOST IN A COMA. HE WENT TO THE HOSPITAL AT 8PM ON 8/23, WHERE HE WAS TREATED WITH DEXTROSE AND GIVEN AN IV PUSH. HE CAME BACK TO THE FACILITY AT 10:00 PM ON 8/23 AND READ 47 WITH THE DEFECTIVE METER, WHEN TESTED WITH ANOTHER METER, HIS ACTUAL READING WAS 347. AT 2:00AM ON 8/24, THE DEFECTIVE METER READ 52, ACTUAL READING WAS 106. THE METER WAS CHECKED WITH CONTROL SOLUTION MULTIPLE TIMES AND EACH TIME WAS WITHIN RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASSURE PLATINUM BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM NBW ARKRAY FACTORY USA, INC. 500050 08030A

    Patients

    Seq Age Sex Outcome Treatment
    1 63102 YR Hospitalization| R