BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX AIR

    MDR report key: 11181520 · Received January 15, 2021

    Report

    Report Number
    1000113657-2021-00035
    Event Type
    Malfunction
    Date Received
    January 15, 2021
    Date of Event
    December 22, 2020
    Report Date
    February 18, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 18-FEB-2021: H6: UPDATED FDA'S METHOD, RESULT, AND CONCLUSION 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 AND PASSED. MOST LIKELY UNDERLINE ROOT CAUSE MOST LIKELY UNDERLINE ROOT CAUSE MLC-058 POOR TECH-INACCURATE REFERENCE.

    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 5-JAN-2021 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER AND STATED IS SATISFIED WITH THE REPLACEMENT PRODUCT.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 173 MG/DL FASTING AND 378 AND 229 MG/DL NON-FASTING. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 102-109 MG/DL; AN EXPECTED NON-FASTING BLOOD GLUCOSE TEST RESULT RANGE WAS NOT PROVIDED. CUSTOMER WAS NOT USING THE PROPER TESTING TECHNIQUE. 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 PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 99 MG/DL AND 168 MG/DL USING THE METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION (DINING AREA). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 03/15/2022 AND TEST STRIPS WERE OPENED TWO DAYS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73017 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX NFRS24/CS 50CT MG/DL MX4402 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1