BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 9687112 · Received February 10, 2020

    Report

    Report Number
    1000113657-2020-00069
    Event Type
    Injury
    Date Received
    February 10, 2020
    Date of Event
    January 13, 2020
    Report Date
    September 24, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 24-SEPT-2021: H6: UPDATED FDA'S TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS. H10: COMPLAINT PRODUCTS WERE NOT RETURNED FOR INVESTIGATION. RETENTION STRIP LOT TESTED AND PASSED, MOST LIKELY UNDERLYING ROOT CAUSE: MLC-62: USER HAD POOR TECHNIQUE MANUFACTURER ACKNOWLEDGES THE LATENESS OF THIS REPORT AND INITIATED THE NECESSARY CORRECTIVE ACTION. MANUFACTURER CORRECTIVE ACTION NUMBER: CAPA-21-008¿.

    Additional Manufacturer Narrative · 0

    CORRECTED SECTIONS AS OF 09-24-2021. H10: MANUFACTURER ACKNOWLEDGES THE LATENESS OF THIS REPORT AND INITIATED THE NECESSARY CORRECTIVE ACTION. MANUFACTURER CORRECTIVE ACTION NUMBER: CAPA-21-007.

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-62: USER HAD POOR TECHNIQUE NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL TO ENSURE THAT THE CUSTOMER'S CONDITION IMPROVED - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME. NO PRODUCT NOTIFICATION LETTER SENT SINCE NO CUSTOMER ADDRESS ON FILE.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR E-5 ACCOMPANIED BY SYMPTOMS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF E-5, E-2 AND 145MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF FEELING SHAKY AND IS SWEATY. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 145MG/DL FASTING USING METER. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 04/25/2021 AND OPEN VIAL DATE IS (B)(6) 2019. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150654 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, GNP TMX 50CT MMMG/DL MW3555S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1