BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX AIR

    MDR report key: 12515560 · Received September 22, 2021

    Report

    Report Number
    1000113657-2021-00611
    Event Type
    Malfunction
    Date Received
    September 22, 2021
    Date of Event
    August 26, 2021
    Report Date
    September 22, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE RETURNED. DEFECT FOUND ON RETURNED STRIPS: HIGH READINGS, E0. REPORTED DEFECT NOT REPRODUCED ON RETURNED METER. PRODUCT EVALUATION HAS BEEN COMPLETED. ROOT CAUSE: RC-061: STORAGE OUTSIDE SPECIFICATIONS. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 09-SEP-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 AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM BACK TO BACK BLOOD TESTS OF 286, 487, 516, 210, 441, 280 AND 297MG/DL. CUSTOMER WAS NOT USING THE PROPER TESTING TECHNIQUE. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150-300MG/DL. CUSTOMER STATED SHE IS NOT STABLE WITH HER BLOOD RESULTS OR DIABETES. 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 NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 12/31/2022 AND TEST STRIPS WERE OPENED ONE WEEK 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
    1414723 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX HMN 50CT24/CASE MG/DL ZY4411S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1