BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRUE METRIX GO

    MDR report key: 9802503 · Received March 6, 2020

    Report

    Report Number
    1000113657-2020-00137
    Event Type
    Death
    Date Received
    March 6, 2020
    Date of Event
    February 6, 2020
    Report Date
    August 26, 2020
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    PMA / PMN Number
    K143548
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 26-AUG-2020: H10: MOST LIKELY UNDERLYING ROOT CAUSE: MLC-28: THERE WAS NOT ENOUGH INFORMATION TO DETERMINE THE MLURC.

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE #(B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. NO ROOT CAUSE COULD BE DETERMINED AT THIS TIME WITH THE INFORMATION AVAILABLE. NOTE: MANUFACTURER ATTEMPTED TO MAKE CONTACT WITH THE NURSE SEVERAL TIMES IN ORDER TO OBTAIN MORE INFORMATION ABOUT THE EVENT. VOICE MESSAGES WERE LEFT TO CALL MANUFACTURER BACK - UNABLE TO MAKE CONTACT WITH NURSE AT THIS TIME. NO PRODUCT NOTIFICATION LETTER SENT SINCE NO CUSTOMER ADDRESS ON FILE. A NURSE AT AN ASSISTED LIVING FACILITY CALLED ABOUT AN E-0 READING ON THE TRUE METRIX GO. DURING CALL, THE EMPLOYEE SAID THAT A PREVIOUS USER OF THE DEVICE HAD DIED AND STATED IT WAS DUE TO THE PRODUCT. SHE DID NOT CLARIFY THE COMMENT, NOR DID SHE RESPOND TO REPEATED ATTEMPTS TO OBTAIN MORE INFORMATION, THEN SHE DISCONNECTED THE CALL. UNABLE TO VERIFY DATE AND TIME OF PATIENT'S DEATH.

    Description of Event or Problem · 1

    ASSISTED LIVING FACILITY NURSE IS CALLING TO INQUIRE ABOUT THE E-0 ERROR AND WHY ERROR IS COMING UP. NURSE DID NOT HAVE THE PRODUCTS (METER/TEST STRIPS) AVAILABLE TO TROUBLESHOOT AT THE TIME OF THE CALL, NEITHER PRODUCT DETAILS (SERIAL NUMBER/LOT NUMBER). NURSE STATED THAT THE PRODUCT DOES NOT BELONG TO THE CURRENT RESIDENT SHE WAS TRYING TO PERFORM A BLOOD GLUCOSE TEST. NURSE STATED THAT THE METER BELONGED TO A PREVIOUS RESIDENT WHO HAD PASSED AWAY AND STATED THAT THE METER WAS KEPT AND IT WAS BEING USED ON CURRENT RESIDENT WHO TEST COUPLE OF TIMES AT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266607 TRUE METRIX GO SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC METER, GO TRUE METRIXMTR ONLY TRIVIDIA MG/DL

    Patients

    Seq Age Sex Outcome Treatment
    1 Death