BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 3382908 · Received September 4, 2013

    Report

    Report Number
    1052693-2013-00197
    Event Type
    Malfunction
    Date Received
    September 4, 2013
    Date of Event
    August 9, 2013
    Report Date
    September 2, 2013
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD GLUCOSE RESULTS. CALLER STATES THAT METER READ AT ONE TIME 488 MG/DL AND TESTING PERFORMED AT THE DOCTORS OFFICE WITHIN 20 MINS WAS 175 MG/DL. METER MEMORY STATES: 252, 206, 182, 327, 488, 217, 207, 274, AND 253 - CUSTOMER UNABLE TO GIVE DATES BUT STATES ALL TESTS PERFORMED 2 HRS AFTER EATING. CUSTOMER STATES HER READINGS SHOULD BE 150-160 MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437810 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUETRACK RP4155

    Patients

    Seq Age Sex Outcome Treatment
    1