BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 11085026 · Received December 28, 2020

    Report

    Report Number
    1000113657-2020-00924
    Event Type
    Injury
    Date Received
    December 28, 2020
    Date of Event
    December 1, 2020
    Report Date
    January 25, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 25-JAN-2021: H10: METER WAS RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED WITH METER. ONLY. NO DEFECT FOUND. TEST STRIPS WERE NOT RETURNED FOR EVALUATION. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT TESTED AND PASSED. MOST LIKELY UNDERLINE ROOT CAUSE MLC-055 ADDED :USER HAD AN INACCURATE REFERENCE: COMPETITORS METER: THE END USER IS COMPARING RESULTS OBTAINED FROM TRIVIDIAS BGM SYSTEM TO THE RESULTS FROM A COMPETITORS 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 8-DEC-2020 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER AND STATED REPLACEMENT PRODUCT RESOLVED INITIAL CONCERN.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR LO/LOW AND HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 132, 126, 123, 254 AND 79 MG/DL AND RESULT OBTAINED OF "LO". DURING REVIEW OF THE METER MEMORY, CUSTOMER ALSO MENTIONED A RESULT OF "04"; TECHNICIAN HAD CONFIRMED SEVERAL TIMES AND CUSTOMER HAD STATED IT ONLY SHOWED ONLY TWO DIGITS, A "0" AND A "4". CUSTOMER STATED HE RECALLED SEEING THE LO AT THE TIME OF THIS TEST, BUT NOT 04. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90-99 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER REPORTED HE HAD FELT JITTERY WHEN THE RESULT OF 132 MG/DL HAD BEEN OBTAINED ON (B)(6) 2020 AND HAD FELT SHAKY WHEN THE RESULT OF 79 MG/DL HAD BEEN OBTAINED ON (B)(6) 2020. NO MEDICAL ATTENTION WAS REPORTED DUE TO THE SYMPTOMS, BUT CUSTOMER REPORTED HE HAD CONTACTED HIS DOCTOR DUE CONCERN WITH THE RESULTS OBTAINED. CUSTOMER STATED THAT A METER TO METER COMPARISON HAD BEEN PERFORMED AT THE DOCTORS AND THE RESULT FROM THE METER WAS 58 POINTS HIGHER THAN THE DOCTOR'S DEVICE (ACTUAL RESULTS WERE NOT PROVIDED). DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 99 MG/DL USING THE METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 03/24/2022 AND OPEN VIAL DATE IS 11/01/2020. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1547114 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX 50CTMG/DL ZX4081S

    Patients

    Seq Age Sex Outcome Treatment
    1 Other