BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 10999141 · Received December 13, 2020

    Report

    Report Number
    1000113657-2020-00894
    Event Type
    Malfunction
    Date Received
    December 13, 2020
    Date of Event
    November 17, 2020
    Report Date
    January 14, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292009120
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 14-JAN-2021: H6: UPDATED FDA'S METHOD, RESULT, AND CONCLUSION CODES: D10/H3: PRODUCT RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED WITH BOTH METER AND STRIPS. NO DEFECT FOUND. MLC-020 ADDED.

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. NOTE: MANUFACTURER CONTACTED CUSTOMER IN SEVERAL FOLLOW-UP CALLS TO ENSURE THE PATIENT CONDITION IMPROVED AND INITIAL CONCERN IS RESOLVED - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 272, 279, 239, 253, 244 AND 228 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90-130 MG/DL; EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE 2- 3 HOURS POST MEAL IS 130-140 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, 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. THE CUSTOMER DID NOT HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1465325 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, CVS TMX 30CT24/CASE MG/DL MX4370S 00021292009120

    Patients

    Seq Age Sex Outcome Treatment
    1