BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 7309805 · Received March 2, 2018

    Report

    Report Number
    1000113657-2018-00257
    Event Type
    Malfunction
    Date Received
    March 2, 2018
    Date of Event
    February 5, 2018
    Report Date
    March 2, 2018
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-22-CLIENT IS TESTING WITH EXPIRED TEST STRIPS (B)(4). MANUFACTURER CONTACTED CUSTOMER ON (B)(6) 2018 IN A FOLLOW-UP CALL IN ORDER 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 SINCE THE LAST CALL.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 251, 138, AND 261MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 TO 130MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE BEDROOM. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/27/18 AND OPEN VIAL DATE IS MONTHS AGO (EXPIRED). THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1:251MG/DL DATE: (B)(6) 2018 TIME:9:24 AM FASTING, RESULT 2:110MG/DL DATE:(B)(6) 2018 TIME:9:49 AM FASTING, RESULT 3:138MG/DL DATE: (B)(6) 2018 TIME:12:30PM FASTING, RESULT 4:251MG/DL DATE:(B)(6) 2018 TIME:11:16AM FASTING, RESULT 5:261MG/DL DATE:(B)(6) 2018 TIME:11:14AM FASTING, CUSTOMER IS CONCERNED WITH THE HIGH RESULTS THAT HE IS GETTING FROM HIS METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153785 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MU2446 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR