BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX AIR

    MDR report key: 15498842 · Received September 28, 2022

    Report

    Report Number
    1000113657-2022-00523
    Event Type
    Injury
    Date Received
    September 28, 2022
    Date of Event
    September 9, 2022
    Report Date
    October 19, 2022
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    0002129200783
    PMA / PMN Number
    K150052
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). ADVERSE EVENT REPORT IS BEING SUBMITTED DUE TO CUSTOMER GOING TO URGENT CARE DUE TO SYMPTOM(S) AND FOR SYMPTOM(S) RELATED TO DIABETES: SWOLLEN ANKLES (CUSTOMER WAS UNABLE TO CONFIRM IF SWOLLEN ANKLES WAS/WAS NOT DUE TO DIABETES). TEST STRIPS WERE NOT RETURNED FOR EVALUATION - CUSTOMER HAD RETURNED AN EMPTY TEST STRIP VIAL. METER WAS RETURNED - PRODUCT EVALUATION IN-PROCESS. NOTE 1: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 13-SEP-2022 TO ENSURE THE CUSTOMER'S CONDITION HAD IMPROVED - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED HER ANKLES WERE STILL SWOLLEN. CUSTOMER STATED THAT SHE WOULD BE HAVING LAB WORK PERFORMED AT THE END OF THE MONTH. NOTE 2: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 20-SEP-2022 TO ENSURE THE CUSTOMER'S CONDITION HAD IMPROVED AND THAT THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED HER ANKLES WERE STILL SWOLLEN. CUSTOMER STATED DUE TO HER SWOLLEN ANKLES, SHE HAD GONE TO URGENT CARE ON (B)(6) 2022. CUSTOMER DID NOT RECEIVE ANY MEDICATION WHEN AT URGENT CARE - CUSTOMER HAD BEEN ADVISED TO ELEVATE HER LEGS AND TO CONTACT HER PRIMARY CARE PHYSICIAN. CUSTOMER STATED THE REPLACEMENT PRODUCTS DID NOT RESOLVE THE INITIAL CONCERN AND REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS (INTERNAL REPORT REFERENCE NUMBER (B)(4)). NOTE 3: MANUFACTURER CONTACTED CUSTOMER IN ADDITIONAL FOLLOW-UP CALL TO ENSURE THE CUSTOMER'S CONDITION HAD IMPROVED - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 19-OCT-2022: H3: WAS THE DEVICE EVALUATED BY THE MANUFACTURER. H6: UPDATED FDA¿S TYPE, FINDINGS AND CONCLUSIONS CODES. H10: METER WAS RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND. TEST STRIPS WERE NOT RETURNED FOR EVALUATION - CUSTOMER HAD RETURNED AN EMPTY TEST STRIP VIAL. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT TESTED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-058: USER HAD AN INACCURATE REFERENCE: SELF: THE PERSON IS USING THEMSELVES AS THE REFERENCE OR HOW THEY FEEL AT THE TIME THEY RUN THE BLOOD TEST.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 152, 145, 143, 144 AND 142 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120-130 MG/DL. AT THE TIME OF THE CALL THE CUSTOMER REPORTED THAT HER ANKLES WERE SWOLLEN; CUSTOMER WAS UNSURE IF IT WAS RELATED TO DIABETES. MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER; CUSTOMER STATED SHE DID NOT HAVE ANY MORE TEST STRIPS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 11/17/2023 AND TEST STRIPS WERE OPENED ONE MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET; ALL ARE AM RESULTS): (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1746727 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX NFRS24/CS 50CT MG/DL ZA4778S 0002129200783

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other