BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4561997 · Received February 26, 2015

    Report

    Report Number
    1052693-2015-00208
    Event Type
    Malfunction
    Date Received
    February 26, 2015
    Date of Event
    February 4, 2015
    Report Date
    February 26, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    LFR
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER EVALUATED WITH FOREIGN MATERIAL ON THE STRIP CONNECTOR.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD RESULTS. VERIFIED THE TEST STRIPS ARE WITHIN THE EXPIRATION DATE (08/28/2017). CALLER STATED HER EXPECTED RANGE IS 140 MG/DL-160 MG/DL. CALLER ALSO STATED THAT SHE HAS LOWS IN THE 50'S. REVIEWED THE RESULTS IN MEMORY: (DATE IS CORRECT, TIME IS WRONG). (B)(6) 2015 1:20 AM 168. (B)(6) 2015 07:56 AM 116. (B)(6) 2015 07:55 AM LO. (B)(6) 2015 07:54 AM LO. (B)(6) 2015 07:53 AM LO. CUSTOMER STATES THEY FEELS FINE AND DOES NOT REQUIRE MEDICAL ATTENTION. CUSTOMER CONFIRMS THAT SHE PERFORMS BLOOD TESTS WHEN FASTING. RAN BACK TO BACK BLOOD TEST, LO, 163 MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137681 TRUERESULT BLOOD GLUCOSE SYSTEM LFR NIPRO DIAGNOSTICS, INC. TRUERESULT PR2086

    Patients

    Seq Age Sex Outcome Treatment
    1