BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4894411 · Received July 1, 2015

    Report

    Report Number
    1052693-2015-01030
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    June 5, 2015
    Report Date
    July 1, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, ICN.
    Product Code
    LFR
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER EVALUATED WITH NO DEFECTS FOUND. RETURNED STRIPS EVALUATED WITH E-2 ERRORS. MOST LIKELY UNDERLYING ROOT CAUSE OF E-2 ERRORS IS SCRATCHES ON TEST STRIPS CAUSED IN MANUFACTURING.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD RESULTS. CUSTOMER STATES THAT SHE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 10-140MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 01/31/2018. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED (B)(6) 2018. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST, 25MG/DL AND 136MG/DL FASTING. REVIEWED METER MEMORY: 1:282MG/DL (B)(6) 2015 05:26:00 PM FASTING: YES. 2:26MG/DL (B)(6) 2015 04:49:00 PM FASTING: YES. 3:26MG/DL (B)(6) 2015 04:48:00 PM FASTING: YES. 4:125MG/DL (B)(6) 2015 02:43:00 PM FASTING: YES. 5:41MG/DL (B)(6) 2015 04:43:00 PM FASTING: YES. THE CUSTOMER ALSO STATES THAT THE DATE AND TIME HAS NEVER BEEN SETUP. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429645 TRUERESULT BLOOD GLUCOSE SYSTEM LFR NIPRO DIAGNOSTICS, ICN. TRUERESULT PS2213

    Patients

    Seq Age Sex Outcome Treatment
    1