BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 3380603 · Received September 4, 2013

    Report

    Report Number
    1052693-2013-00221
    Event Type
    Malfunction
    Date Received
    September 4, 2013
    Date of Event
    August 23, 2013
    Report Date
    September 3, 2013
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    CGA
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD GLUCOSE RESULTS. CUSTOMER STATES THAT THE TRUETRACK METER IS READING ANYWHERE FROM 110-130 MG/DL AND HER OTHER METERS ARE READING 60 TO 70 MG/DL AND SHE FEELS THAT HER GLUCOSE IS LOW (SLUGGISH, DIZZY, SHAKY). CUSTOMER REFUSED TO REVIEW MEMORY. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438059 TRUETRACK BLOOD GLUCOSE SYSTEM CGA NIPRO DIAGNOSTICS, INC. TRUETRACK RM3740

    Patients

    Seq Age Sex Outcome Treatment
    1