BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4702043 · Received April 15, 2015

    Report

    Report Number
    1052693-2015-00519
    Event Type
    Malfunction
    Date Received
    April 15, 2015
    Date of Event
    March 20, 2015
    Report Date
    April 15, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT YET RETURNED FOR EVALUATION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE IS: TEST STRIP ISSUE.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF BLOOD RESULT READING OF "HI". CUSTOMER STATES THAT SHE FEELS WELL, REQUIRES NO MEDICAL ATTENTION BUT THAT SHE IS URINATING A LOT AFTER SHE STARTED HER STEROID INJECTION TREATMENT YESTERDAY. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 190MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 04/23/2017 AND WERE FIRST OPENED (B)(6) 2015. CUSTOMER CONFIRMS THE STRIPS WERE STORED CORRECTLY. CUSTOMER RAN A BACK TO BACK BLOOD TEST, HI AND HI NOT FASTING. REVIEWED METER MEMORY: HI; (B)(6) 2015; 12:00:00 AM; FASTING: NO, HI; (B)(6) 2015; 12:00:00 AM; FASTING: NO, HI; (B)(6) 2015; 12:00:00 AM; FASTING: NO, HI; (B)(6) 2015; 12:00:00 AM; FASTING: NO, 516MG/DL; (B)(6) 2015; 07:00:00 PM; FASTING: NO. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252574 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR1935

    Patients

    Seq Age Sex Outcome Treatment
    1