BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRUE METRIX

    MDR report key: 16479716 · Received March 3, 2023

    Report

    Report Number
    1000113657-2023-00130
    Event Type
    Death
    Date Received
    March 3, 2023
    Date of Event
    February 3, 2023
    Report Date
    March 30, 2023
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292009120
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). ADDITIONAL REPORT REFERENCE NUMBER: (B)(4) ¿ SAME TEST STRIP LOT NUMBER, DIFFERENT METER SERIAL NUMBER. ADVERSE EVENT REPORT BEING SUBMITTED DUE TO MANUFACTURER BEING UNABLE TO CONFIRM WITH CUSTOMER'S WIFE THE CAUSE OF THE CUSTOMER'S DEATH AND ADDITIONAL DETAILS FROM THE INITIAL INFORMATION PROVIDED (SYMPTOMS). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. NOTE 1: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 08-FEB-2023 - ABLE TO ESTABLISH CONTACT WITH CUSTOMER'S WIFE WHO STATED THAT CUSTOMER HAD PASSED AWAY. WIFE DECLINED TO CONTINUE THE CALL. NOTE 2: MANUFACTURER WAS UNABLE TO CONTACT WIFE AT ADDITIONAL FOLLOW-UP ATTEMPTS. MANUFACTURER UNABLE TO CONFIRM CUSTOMER'S CAUSE OF DEATH.

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 30-MAR-2023: H6: UPDATED FDA'S TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS. H10: METER WAS NOT RETURNED FOR EVALUATION. TEST STRIPS WERE NOT RETURNED FOR EVALUATION. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIPS TESTED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-078: USER HEMATOCRIT LOW.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR ERROR MESSAGE (E-0). WIFE IS CALLING ON BEHALF OF THE CUSTOMER. CUSTOMER REPORTED OBTAINING THE E-0 ERROR USING TWO DIFFERENT VIALS OF TEST STRIPS; CUSTOMER HAD DISCARDED THE EMPTY VIAL AND WAS UNABLE TO PROVIDE THE LOT NUMBER. CUSTOMER STATED THIS IS THEIR SECOND TRUE METRIX METER. WIFE STATED THAT THE CUSTOMER CURRENTLY DOES NOT FEEL WELL; CUSTOMER DID NOT SPECIFY WHAT HE WAS FEELING AT THE TIME. WIFE STATED THAT CUSTOMER WAS SCREAMING AS IF HE IS IN PAIN, STATING THIS IS AN ONGOING SYMPTOM AND THAT WHEN IT OCCURS, SHE CHECKS HIS BLOOD GLUCOSE. WIFE STATED THAT BASED ON THE RESULT SHE ADMINISTERS INSULIN AND THEN HE STOPS SCREAMING AND BEGINS TO FEEL BETTER. WIFE STATED THAT THIS STARTED PRIOR TO CUSTOMER OBTAINING THE TRUE METRIX METERS, CUSTOMER DID NOT NEED MEDICAL ATTENTION AT THE TIME OF THE CALL. DURING THE CALL, A BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER USING THIS TRUE METRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 04/30/2024 AND OPEN VIAL DATE IS (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1947523 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, WGN TMX 60CT 12/CASE MG/DL ZA4953S 00021292009120

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death