BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 8345062 · Received February 15, 2019

    Report

    Report Number
    1000113657-2019-00138
    Event Type
    Malfunction
    Date Received
    February 15, 2019
    Date of Event
    January 22, 2019
    Report Date
    February 15, 2019
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007928
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT # (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. RETURNED TEST STRIPS EVALUATED WITH DEFECT FOUND. QC INVESTIGATION ON 1/31/2019 RETURNED TEST STRIPS PRODUCE LO READINGS. MOST LIKELY UNDERLYING ROOT CAUSE OF LOW READINGS ARE DUE TO IMPROPER STORAGE: VIAL LEFT OPEN FOR AN EXTENDED PERIOD OF TIME. TEST STRIP UDI# (B)(4). NOTE: MANUFACTURER CONTACTED CUSTOMER (SEVERAL ATTEMPTS) IN A FOLLOW-UP CALL TO ENSURE THAT THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH THE CUSTOMER AT THIS TIME.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR LO BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF LO. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 142 - 180 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL ON (B)(6) 2019, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/30/2019 AND TEST STRIPS WERE OPENED MORE THAN FOUR MONTHS AGO (EXPIRED). THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER WAS NOT ABLE TO ACCESS THE MEMORY RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135741 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MU2669 00021292007928

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR