BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX AIR

    MDR report key: 11596074 · Received March 31, 2021

    Report

    Report Number
    1000113657-2021-00216
    Event Type
    Injury
    Date Received
    March 31, 2021
    Date of Event
    March 4, 2021
    Report Date
    March 31, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007720
    PMA / PMN Number
    K150052
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). TEST STRIPS WERE NOT RETURNED FOR EVALUATION. METER WAS RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-055: USER HAD AN INACCURATE REFERENCE: COMPETITOR¿S METER: THE END USER IS COMPARING RESULTS OBTAINED FROM TRIVIDIA¿S BGM SYSTEM TO THE RESULTS FROM A COMPETITOR¿S BGM SYSTEM. NOTE: MANUFACTURER CONTACTED CUSTOMER IN SEVERAL FOLLOW-UP CALLS TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

    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 260, 182, 195, 243, 225 AND 218 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 130-150 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT ON (B)(6) 2021 SHE HAD GONE TO URGENT CARE DUE TO THE HIGH BLOOD GLUCOSE TEST RESULTS OBTAINED. CUSTOMER STATED SHE HAD TESTED NON-FASTING IN THE MORNING AND HAD OBTAINED A BLOOD GLUCOSE TEST RESULT IN THE 200'S. CUSTOMER HAD TAKEN 30 UNITS OF MEDICATION (UNDISCLOSED) AND TWO METFORMIN. CUSTOMER HAD TESTED AGAIN (DID NOT DISCLOSE TIMEFRAME BETWEEN TESTS) AND STATED THE RESULT OBTAINED WAS STILL IN THE 200'S. CUSTOMER STATED SHE HAD GONE TO URGENT CARE THREE HOURS LATER; CUSTOMER'S BLOOD GLUCOSE TEST RESULT AT URGENT CARE WAS 146 MG/DL FASTING. CUSTOMER DID NOT REPORT ANY MEDICAL TREATMENT RECEIVED WHILE AT URGENT CARE AND STATED SHE HAD BEEN ADVISED TO REPLACE THE TRUEMETRIX AIR METER. 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 05/25/2022 AND TEST STRIPS WERE OPENED TWO WEEKS 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
    492455 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC KIT, RLN AIR TMX METER MG/DL ZX4151S 00021292007720

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention