BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRUE METRIX AIR

    MDR report key: 12685853 · Received October 22, 2021

    Report

    Report Number
    1000113657-2021-00668
    Event Type
    Death
    Date Received
    October 22, 2021
    Date of Event
    August 31, 2021
    Report Date
    November 29, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K150052
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 29-NOV-2021: H6: UPDATED FDA¿S TYPE, FINDINGS AND CONCLUSIONS CODES. 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 STRIP LOT TESTED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-062: USER HAD POOR TECHNIQUE.

    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-062: USER HAD POOR TECHNIQUE. NOTE 1: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON (B)(6) 2021 TO ENSURE THAT THE INITIAL CONCERN WAS RESOLVED - ABLE TO ESTABLISH CONTACT WITH CAREGIVER WHO STATED THAT THE CUSTOMER PASSED AWAY. CAREGIVER STATED THAT CUSTOMER'S BLOOD GLUCOSE HAD BEEN 600MG/DL (FASTING/NON-FASTING STATUS NOT DISCLOSED). CAREGIVER DID NOT PROVIDE ANY FURTHER INFORMATION. NOTE 2: MANUFACTURER CONTACTED CAREGIVER IN A FOLLOW-UP CALL ON (B)(6) 2021 - CAREGIVER STATED THAT CUSTOMER WAS A VERY BRITTLE DIABETIC AND THAT THE DOCTOR GAVE HIM 6 MONTHS TO LIVE A FEW YEARS AGO DUE TO HIM BEING "TERMINAL" AS ALL OF HIS ORGANS BEGAN FAILING. CUSTOMER WAS ON HOSPICE AND PASSED AWAY IN HIS SLEEP. CAREGIVER STATED HIS MOTHER PASSED AS WELL 6 WEEKS AGO AND THEY WERE CLOSE AND EXPECTING HIM TO PASS SOON AFTER. CAREGIVER STATED SHE DOES BELIEVE HIS DEATH WAS RELATED TO HIM BEING A TERMINAL DIABETIC. CAREGIVER STATED SHE GAVE THE METER TO SOMEONE ELSE THAT NEEDS IT AND NO LONGER HAS IT.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR ERROR MESSAGES (E-3 AND E-5). CAREGIVER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE CUSTOMER WAS NOT USING THE PROPER TESTING TECHNIQUE. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED E-5 ERROR USING TRUE METRIX AIR METER. CAREGIVER STATED CUSTOMER'S GLUCOSE RUNS HIGH AROUND THIS TIME AND THAT HE HAD NOT TAKEN HIS INSULIN. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE HALLWAY CLOSET. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 10/31/2022 AND TEST STRIPS WERE OPENED A FEW DAYS PRIOR TO THE CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1581589 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX GNP 100CTMG/DL ZY4329S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death