BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 11382693 · Received February 25, 2021

    Report

    Report Number
    1000113657-2021-00149
    Event Type
    Malfunction
    Date Received
    February 25, 2021
    Date of Event
    February 2, 2021
    Report Date
    April 19, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 19-APR-2021: H6: UPDATED FDA¿S TYPE, FINDINGS AND CONCLUSIONS CODES. 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 UNDERLYING ROOT CAUSE: MLC-058: USER HAD AN INACCURATE REFERENCE: SELF: THE PERSON IS USING THEMSELVES AS THE REFERENCE OR HOW THEY FEEL AT THE TIME THEY RUN THE BLOOD TEST.

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON (B)(6) 2021 TO ENSURE THE CUSTOMER'S CONDITION HAD IMPROVED AND THAT THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN, ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED SHE WAS NO LONGER EXPERIENCING SYMPTOMS AND NO ADVERSE EVENT HAD OCCURRED. CUSTOMER STATED THE REPLACEMENT PRODUCT RESOLVED INITIAL CONCERN.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 211, 152 AND 119 MG/DL. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS 96 MG/DL AND EXPECTED 2 HOURS POST MEAL FASTING BLOOD GLUCOSE TEST RESULT IS 110 MG/DL. AT THE TIME OF THE CALL THE CUSTOMER REPORTED FEELING DIZZY, MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 77 MG/DL AND 71 MG/DL USING THE METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 12/16/2021 AND OPEN VIAL DATE IS 01/2021. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (CUSTOMER WAS ONLY CONCERNED WITH THE HIGH RESULTS). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279053 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX GNP 50CTMG/DL MX4283S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1