BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX AIR

    MDR report key: 11661227 · Received April 13, 2021

    Report

    Report Number
    1000113657-2021-00253
    Event Type
    Malfunction
    Date Received
    April 13, 2021
    Date of Event
    March 17, 2021
    Report Date
    May 17, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF (B)(6)2021: D8: WAS THIS DEVICE SERVICED BY A THIRD PARTY. D9: DEVICE AVAILABLE FOR EVALUATION. H2 DEVICE EVALUATED BY MANUFACTURER. H6: UPDATED FDA'S TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS H10: METER AND STRIPS WERE RETURNED FOR EVALUATION. REPORTED DEFECT NOT REPRODUCED.- NO DEFECT FOUND MOST LIKELY UNDERLYING ROOT MLC-058 CAUSE 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. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 31-MAR-2021 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED REPLACEMENT PRODUCTS 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 243, 315, 250, 335 AND 326MG/DL. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80-120MG/DL AND EXPECTED RESULT TWO HOURS POST MEAL IS 150MG/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 BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 230MG/DL USING TRUE METRIX AIR METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 04/28/2022 AND TEST STRIPS WERE OPENED A FEW DAYS PRIOR TO CALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557998 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX NFRS24/CS 50CT MG/DL MX4418S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1