BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 11605570 · Received April 1, 2021

    Report

    Report Number
    1000113657-2021-00222
    Event Type
    Injury
    Date Received
    April 1, 2021
    Date of Event
    March 1, 2021
    Report Date
    May 11, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 11-MAY-2021: 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 STRIP LOT TESTED WITHIN SPECIFICATIONS MOST LIKELY UNDERLINE ROOT CAUSE MLC-055 USER HAD AN INACCURATE REFERENCE: COMPETITOR¿S METER: THE END USER IS COMPARING RESULTS OBTAINED FROM TRIVIDIA¿S BGM SYSTEM TO THE RESULTS FROM A COMPETITOR¿S BGM SYSTEM.

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 11-MAR-2021 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR ERRATIC AND HIGH BLOOD GLUCOSE TEST RESULTS. CUSTOMER HAS ONLY BEEN USING THE TRUE METRIX METER FOR 3 WEEKS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 184, 260, 161, 217 AND 200MG/DL. THE CUSTOMER DOES NOT KNOW HER EXPECTED GLUCOSE RANGE. AT THE TIME OF THE CALL THE CUSTOMER WAS CURRENTLY IN THE HOSPITAL. CUSTOMER STATED DURING HER SCHEDULED OBGYN CHECKUP ON (B)(6) 2021, HER DOCTOR REVIEWED HER LOGBOOK AND ADVISED HER TO GO TO THE HOSPITAL DUE TO THE HIGH RESULTS. CUSTOMER WAS ALSO CONCERNED THE RESULTS FROM THE TRUE METRIX METER WERE HIGHER WHEN COMPARED TO THE HOSPITAL METER; ACTUAL METER TO METER COMPARISON RESULTS WERE NOT PROVIDED. CUSTOMER HAD NOT BEEN USING THE PROPER TESTING TECHNIQUE FOR THE METER TO METER COMPARISON TESTS. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 04/30/2022 AND OPEN VIAL DATE IS THREE WEEKS PRIOR TO CALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502561 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX CVS 50CT24/CASE MG/DL ZX4118S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization