BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4562008 · Received February 26, 2015

    Report

    Report Number
    1052693-2015-00191
    Event Type
    Malfunction
    Date Received
    February 26, 2015
    Date of Event
    February 1, 2015
    Report Date
    February 26, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    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 AND TEST STRIPS EVALUATED WITH NO DEFECTS FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION. USER HAD AN INACCURATE REFERENCE.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD RESULTS. STRIPS ARE IN DATE. VERIFIED CUSTOMER IS USING PROPER TESTING TECHNIQUE. CUSTOMER RAN A BACK TO BACK BLOOD TEST: 103 MG/DL AND 109 MG/DL. THE CUSTOMER ATE ABOUT 5 HOURS AGO. THE PATIENT FEELS FINE. CUSTOMER STATED THAT HER EXPECTED BLOOD GLUCOSE RANGE IS 167-200 MG/DL, BEFORE EATING. CUSTOMER RAN A BLOOD TEST IN THE MORNING AND RECEIVED A 107 MG/DL, BEFORE EATING. REVIEWED LAST FIVE RESULTS FROM MEMORY: THE TIME IS NOT SET, 107 MG/DL, 2-1, 8:50 AM, 5 HOURS AFTER EATING; 98 MG/DL, 2-1, 1:25 AM, 4.5 AFTER EATING; 56 MG/DL, 1-31, 8:05 AM, 6 HOURS AFTER EATING; 84 MG/DL, 1-31, 2:05 PM, 4 HOURS AFTER EATING; 81 MG/DL, 1-31, 5:20 AM, BEFORE EATING. CUSTOMER IS CONCERNED OVER DIFFERENCES IN HER RESULTS. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137355 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR2025

    Patients

    Seq Age Sex Outcome Treatment
    1