BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 15737794 · Received November 4, 2022

    Report

    Report Number
    1000113657-2022-00581
    Event Type
    Malfunction
    Date Received
    November 4, 2022
    Date of Event
    October 10, 2022
    Report Date
    December 1, 2022
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. ADDED MOST LIKELY UNDERLYING ROOT CAUSE ONTO CASE AS THE COMPLAINT PRODUCT WAS NOT RETURNED FOR INVESTIGATION. MOST LIKELY UNDERLYING 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 NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 19-OCT-2022 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED THE INITIAL ISSUE HAS BEEN RESOLVED. THE CUSTOMER STATED THAT SHE WILL NO LONGER BE STICKING HER FINGER FOR BLOOD GLUCOSE READINGS AS SHE IS GOING TO BE EATING HEALTHY AND TRUSTING IN THE LORD TO HEAL HER.

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 01-DEC-2022: H3: DEVICE EVALUATED BY MANUFACTURER. H6: UPDATED FDA'S TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS. H10: METER WAS RETURNED FOR EVALUATION. TEST STRIPS WERE NOT RETURNED FOR EVALUATION. REPORTED DEFECT NOT REPRODUCED ON RETURNED METER AND MOST LIKELY UNDERLYING ROOT CAUSE SELECTED. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIPS TESTED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING 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.

    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 187, 220, 194 AND 142 MG/DL. CUSTOMER ALSO STATED THAT THE TRUE METRIX RESULTS WERE HIGHER COMPARED TO ANOTHER DEVICE. THE CUSTOMER¿S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE IS 80-100 MG/DL AM FASTING AND 130-140 MG/DL 2 HRS. AFTER MEALS. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULT OF 200 MG/DL USING TRUE METRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 02/29/2024 AND OPEN VIAL DATE IS 10/05/2022. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 187 MG/DL DATE: (B)(6) 2022 TIME: 11:43 AM FASTING, RESULT 2: 220 MG/DL DATE: (B)(6) 2022 TIME: 11:01 AM FASTING , RESULT 3: 194 MG/DL DATE: (B)(6) 2022 TIME: 8:50 AM FASTING , RESULT 4: 142 MG/DL DATE: (B)(6) 2022 TIME: 9:53 PM 4 HRS. AFTER MEAL, RESULT 5: 194 MG/DL DATE: (B)(6) 2022 TIME: 8:21 PM 3 ½ HRS AFTER MEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2549103 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, GNP TMX 50CT MMMG/DL ZA4884S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown