BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4651223 · Received March 26, 2015

    Report

    Report Number
    1052693-2015-00337
    Event Type
    Malfunction
    Date Received
    March 26, 2015
    Date of Event
    March 4, 2015
    Report Date
    March 9, 2015
    Manufacturer
    NIIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER AND TEST STRIPS EVALUATED WITH NO DEFECTS FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: TEST STRIP ISSUE.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ERRATIC BLOOD RESULTS. CUSTOMER HAS GESTATIONAL DIABETES. SHE STATES HER EXPECTED RANGE IS 95/MG/DL - 100MG/DL. CUSTOMER STATES SHE FELT FINE NO SYMPTOMS NOTICED; SHE ALSO STATES THAT WHEN HER BLOOD SUGAR WAS HIGH OR LOW SHE WOULD FEEL SYMPTOMS. CUSTOMER CONCERNED ABOUT DIFFERENT RESULTS SHE DID BACK TO BACK. VERIFIED STRIPS EXPIRE 11/30/2017 AND WERE FIRST OPENED (B)(6) 2015. CUSTOMER CONFIRMS THE STRIPS ARE STORED CORRECTLY. CUSTOMER RAN BACK TO BACK BLOOD TEST 72/MG/DL AND 72/MG/DL - FASTING. REVIEWED BLOOD RESULT IN METER MEMORY: 74 MG/DL (B)(6) 2015, 11:30:00 AM, 74 MG/DL (B)(6) 2015, 11:36:00 AM, 84 MG/DL (B)(6) 2015, 11:22:00 AM, 85 MG/DL (B)(6) 2015, 11:21:00 AM, 172 MG/DL (B)(6) 2015, 11:20:00 AM. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202028 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIIPRO DIAGNOSTICS, INC. TRUERESULT PP2177

    Patients

    Seq Age Sex Outcome Treatment
    1