BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE RESULT

    MDR report key: 4999199 · Received August 6, 2015

    Report

    Report Number
    1052693-2015-01341
    Event Type
    Malfunction
    Date Received
    August 6, 2015
    Date of Event
    July 9, 2015
    Report Date
    August 4, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ABOUT HIGH BLOOD RESULTS. CUSTOMER STATES THAT SHE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 100-150MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 04/03/2015. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY, AND WAS FIRST OPENED (B)(6) 2015, CUSTOMER'S CONCERN ABOUT ALL HIGH RESULTS. REVIEWED METER MEMORY: 193MG/DL (B)(6) 2015 12:40:00 AM FASTING: YES; 237MG/DL (B)(6) 2015 01:13:00 PM FASTING: YES; 329MG/DL (B)(6) 2015 05:36:00 PM FASTING: YES; 251MG/DL (B)(6) 2015 07:06:00 PM FASTING: YES; 435MG/DL (B)(6) 2015 03:00:00 PM FASTING: YES. ADVERSE EVENT NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520242 TRUE RESULT BLOOD GLUCOSE SYSTEM LFR NIPRO DIAGNOSTICS, ICN. TRUE RESULT PS2298

    Patients

    Seq Age Sex Outcome Treatment
    1