BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 14658908 · Received June 10, 2022

    Report

    Report Number
    1000113657-2022-00333
    Event Type
    Malfunction
    Date Received
    June 10, 2022
    Date of Event
    May 16, 2022
    Report Date
    July 15, 2022
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). TEST STRIPS WERE NOT RETURNED FOR EVALUATION. METER WAS RETURNED - PRODUCT EVALUATION IN-PROCESS. MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 10-JUN-2022 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED REPLACEMENT PRODUCTS RESOLVED INITIAL CONCERN.

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 15-JULY-2022: H3: DEVICE EVALUATED BY MANUFACTURER. H6: UPDATED FDA'S TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS. H10: REPORTED DEFECT NOT REPRODUCED ON RETURNED METER. PRODUCT EVALUATION HAS BEEN COMPLETED. 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 181, 215 AND 243 MG/DL. CUSTOMER STATED THE TRUE METRIX METER RESULTS WERE HIGHER THAN HIS PREVIOUS METER; CUSTOMER DID NOT PROVIDE ACTUAL METER TO METER COMPARISON TEST RESULTS. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100-140 MG/DL AND EXPECTED PM FASTING BLOOD GLUCOSE TEST RESULT IS 150 MG/DL. 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 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 08/31/2023 AND TEST STRIPS WERE OPENED ONE WEEK PRIOR TO CALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 181 MG/DL. DATE: (B)(6). TIME 9:53 AM. FASTING. RESULT 2: 174 MG/DL DATE: (B)(6). TIME: 5:22 AM. FASTING. RESULT 3: 215 MG/DL DATE: (B)(6). TIME: 11:00 PM. FASTING. RESULT 4: 243 MG/DL DATE: (B)(6). TIME: 9:11 PM. FASTING. RESULT 5: 164 MG/DL DATE: (B)(6). TIME: 1:44 PM. NON FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761723 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX MEDIMEDI 50CT MG/DL ZY4672S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown