BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 11342702 · Received February 18, 2021

    Report

    Report Number
    1000113657-2021-00124
    Event Type
    Malfunction
    Date Received
    February 18, 2021
    Date of Event
    January 26, 2021
    Report Date
    April 6, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 06-APR-2021: D8: WAS THIS DEVICE SERVICED BY A THIRD PARTY. D9: DEVICE AVAILABLE FOR EVALUATION. H3 DEVICE EVALUATED BY MANUFACTURER. H6: UPDATED FDA¿S TYPE, FINDINGS AND CONCLUSIONS CODES. H10: TEST STRIPS WERE NOT RETURNED FOR EVALUATION. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT TESTED WITHIN SPECIFICATIONS. METER WAS RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND. 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.

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. COMPLAINT FROM SAME CUSTOMER, DIFFERENT PRODUCT - LINKED WITH THE INTERNAL REFERENCE CASE (B)(4). NOTE: MANUFACTURER CONTACTED CUSTOMER A FOLLOW-UP CALL TO ENSURE THE INITIAL CONCERN IS RESOLVED. UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH AND LOW BLOOD GLUCOSE TEST RESULTS. CUSTOMER HAD CALLED PREVIOUSLY AND HAD RECEIVED REPLACEMENT TEST STRIPS AND CONTROL SOLUTIONS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 182, 344 AND 288 MG/DL AND FROM BACK TO BACK BLOOD TEST RESULTS OBTAINED ON CALL OF 63 AND 77 MG/DL. CUSTOMER STATED HER BLOOD GLUCOSE TEST RESULT USING ANOTHER DEVICE AT THE TIME OF THE BACK TO BACK BLOOD TEST WAS 92 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150-250 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. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING, DINING AND BEDROOMS. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 03/16/2022 AND OPEN VIAL DATE IS 01/26/2021. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243245 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX 50CTMG/DL MX4422S

    Patients

    Seq Age Sex Outcome Treatment
    1