BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRUE METRIX

    MDR report key: 12221030 · Received July 23, 2021

    Report

    Report Number
    1000113657-2021-00452
    Event Type
    Death
    Date Received
    July 23, 2021
    Date of Event
    June 25, 2021
    Report Date
    July 23, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007928
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. NOTE 1: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 13-JUL-2021 TO ENSURE CUSTOMER RECEIVED THE REPLACEMENT PRODUCTS - ABLE TO ESTABLISH CONTACT WITH CUSTOMER'S MOTHER WHO STATED CUSTOMER IS DECEASED AND SHE HAD PASSED AWAY ON (B)(6) 2021. MOTHER STATED SHE DID NOT KNOW THE CAUSE OF DEATH. NOTE 2: MANUFACTURER CONTACTED CUSTOMER IN A SECOND FOLLOW-UP CALL ON 21-JUL-2021 - ABLE TO ESTABLISH CONTACT WITH CUSTOMER'S SISTER WHO STATED THE CAUSE OF DEATH IS STILL UNKNOWN AS THEY HAVE NOT YET RECEIVED THE PAPERWORK. MANUFACTURER REQUESTED THE PRODUCTS BE RETURNED. SISTER STATED SHE WOULD HAVE TO LOCATE THE PRODUCTS AND REQUESTED TO CALL BACK IN A LATER TIME. NOTE 3: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 22-JUL-2021 - MANUFACTURER WAS UNABLE TO ESTABLISH ADDITIONAL CONTACT WITH CUSTOMER'S SISTER AT THIS TIME.

    Description of Event or Problem · 1

    CONSUMER INITIAL INQUIRY WAS TO FIND OUT HOW TO RECHARGE HER TRUE METRIX METER AS DID NOT POWERED-ON. CUSTOMER STATED THE TRUE METRIX METER HAD BELONGED TO HER DECEASED HUSBAND (VETERAN) WHO DIE ALMOST 1 YEAR AGO (CAUSE OF DEATH WAS NOT DISCLOSED). CUSTOMER HAS BEEN USING THE TRUE METRIX METER FOR FEW MONTHS ONLY. CUSTOMER HAS NEVER CHANGED THE BATTERY AND DURING THE CALL, BATTERY WAS REMOVED AND RE-INSERTED BACK (RESET) AND THE TRUE METRIX METER POWERED ON USING THE POWER BUTTON AND WHEN A TEST STRIP WAS INSERTED. THE CUSTOMER DECLINED TO PERFORM A BLOOD TEST. CUSTOMER WAS OFFERED A REPLACEMENT PRODUCT SINCE MANUFACTURER RECOMMENDATION IS SINGLE PATIENT USE ONLY. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION WAS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1116514 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC KIT, TMX NFRS STARTERMG/DL ZY4333S 00021292007928

    Patients

    Seq Age Sex Outcome Treatment
    1