BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUETRACK

    MDR report key: 11995248 · Received June 14, 2021

    Report

    Report Number
    1000113657-2021-00379
    Event Type
    Injury
    Date Received
    June 14, 2021
    Date of Event
    May 18, 2021
    Report Date
    June 14, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007638
    PMA / PMN Number
    K032657
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). ADVERSE EVENT REPORT IS BEING SUBMITTED DUE TO SYMPTOMS RELATED TO DIABETES (UNDISCLOSED). METER WAS NOT RETURNED FOR EVALUATION. NOTE: MANUFACTURER CONTACTED CUSTOMER IN SEVERAL FOLLOW-UP CALLS TO ENSURE THE CUSTOMER'S CONDITION HAD IMPROVED AND THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR DEFECTIVE LCD. CUSTOMER STATED THE TRUE TRACK METER SCREEN HAS INK SPOTS. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED NOT FEELING WELL AND DID NOT SPECIFY HER SYMPTOMS. CUSTOMER STATED SHE MAY/MAY NOT SEEK MEDICAL ATTENTION; CUSTOMER STATED SHE WANTED TO CONTINUE THE CALL. CUSTOMER STATED THE METER HAS NOT BEEN DROPPED AND THERE IS NO PHYSICAL DAMAGE TO THE METER. CUSTOMER DID NOT TAKE ANY MEDICATION BASED ON THE RESULTS. CUSTOMER'S TEST STRIPS ARE EXPIRED: MANUFACTURER¿S EXPIRATION DATE IS 07/31/2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888278 TRUETRACK SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC KIT, SUNMARK (RETAIL)STARTER TT RV5242 00021292007638

    Patients

    Seq Age Sex Outcome Treatment
    1 Other