BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRUE METRIX

    MDR report key: 16685500 · Received April 5, 2023

    Report

    Report Number
    1000113657-2023-00185
    Event Type
    Death
    Date Received
    April 5, 2023
    Date of Event
    March 8, 2023
    Report Date
    May 3, 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
    WA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). ADVERSE EVENT REPORT BEING SUBMITTED DUE TO MANUFACTURER BEING UNABLE TO CONFIRM WITH WIFE THE CAUSE OF THE CUSTOMER'S DEATH. METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-062: USER HAD POOR TECHNIQUE. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON (B)(6) 2023 TO ENSURE THAT THE INITIAL CONCERN WAS RESOLVED. ABLE TO ESTABLISH CONTACT WITH CUSTOMER¿S WIFE WHO STATED THAT THE CUSTOMER HAD ¿EXPIRED.¿ WIFE REQUESTED THAT MANUFACTURER NOT CALL HER AGAIN AND PROCEEDED TO DISCONNECT THE CALL. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED; CUSTOMER¿S CAUSE OF DEATH COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 03-MAY-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. MLC-062: USER HAD POOR TECHNIQUE.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR UNKNOWN ERROR MESSAGE. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. WIFE STATED THAT CUSTOMER WAS CURRENTLY IN THE HOSPITAL, BUT THAT IT WAS NOT DUE TO DIABETES, IT WAS DUE TO PNEUMONIA. CUSTOMER WAS NOT AVAILABLE FOR TESTING AT THE TIME OF THE CALL. WIFE STATED THAT SHE WAS GOING TO THE HOSPITAL THAT DAY AND WOULD TAKE THE SUPPLIES WITH HER AND WOULD CALL BACK. MANUFACTURER ATTEMPTED TO CONTACT CUSTOMER ON (B)(6) 2023 TO ENSURE THE INITIAL CONCERN WAS RESOLVED ¿ MANUFACTURER WAS UNABLE TO ESTABLISH CONTACT WITH CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2242546 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, WGN TMX 60CT 12/CASE MG/DL ZA4952S 00021292009120

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death