BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 8387989 · Received March 4, 2019

    Report

    Report Number
    1000113657-2019-00173
    Event Type
    Malfunction
    Date Received
    March 4, 2019
    Date of Event
    February 11, 2019
    Report Date
    March 4, 2019
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007638
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURER CONTACTED CUSTOMER ON 2/26/2019 IN A FOLLOW-UP CALL TO ENSURE THAT THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN; CUSTOMER STATED THAT THE REPLACEMENT PRODUCT IS WORKING TO THEIR SATISFACTION AND THEY HAVE NOT HAD ANY MEDICAL INTERVENTION OR SYMPTOMS SINCE THE LAST CALL.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS OF 161, 219, 226, 223 AND 208 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 110 - 130 MG/DL. CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT HE PURCHASED THE TRUETRACK METER AFTER DISCHARGE FROM THE HOSPITAL DUE A HEART ATTACK AND STARTED USING THE PRODUCT YESTERDAY. DURING THE CALL ON 02/11/2019, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE BATHROOM. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/17/2021 AND OPEN VIAL DATE IS 02/10/2019. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1:161MG/DL DATE:2/11/2019 TIME:751AM FASTING. RESULT 2:219MG/DL DATE:2/10/2019 TIME:630PM FASTING. RESULT 3:226MG/DL DATE:2/10/2019 TIME:600PM FASTING. RESULT 4:223MG/DL DATE:2/10/2019 TIME:552PM FASTING. RESULT 5:208MG/DL DATE:2/10/2019 TIME:1152AM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180031 TRUETRACK BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUETRACK RV5303 00021292007638

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR