BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX AIR

    MDR report key: 12696706 · Received October 26, 2021

    Report

    Report Number
    1000113657-2021-00675
    Event Type
    Malfunction
    Date Received
    October 26, 2021
    Date of Event
    September 29, 2021
    Report Date
    November 16, 2021
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 16-NOV-2021: H3: WAS THE DEVICE EVALUATED BY THE MANUFACTURER. H6: UPDATED FDA¿S TYPE, FINDINGS AND CONCLUSIONS CODES. H10: 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-062: USER HAD POOR TECHNIQUE.

    Additional Manufacturer Narrative · 0

    (B)(4). TEST STRIPS WERE NOT RETURNED FOR EVALUATION. METER WAS RETURNED - PRODUCT EVALUATION IN-PROCESS. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 05-OCT-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 · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 244, 173, 201 AND 219 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 125-140 MG/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. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DEN. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 11/16/2022 AND OPEN VIAL DATE WAS NOT DISCLOSED. CUSTOMER STATED THAT SHE DID NOT HAVE ANY MORE TEST STRIPS IN THIS VIAL. THE CUSTOMER HAD ANOTHER VIAL OF TEST STRIPS OPENED DAY OF CALL: LOT NUMBER MY4483S, MANUFACTURER'S EXPIRATION DATE OF 02/28/2023. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 195 MG/DL AND 170 MG/DL USING TRUE METRIX AIR METER; CUSTOMER WAS NOT SATISFIED WITH THE RESULTS OBTAINED. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (CUSTOMER STATED SHE DID NOT RECALL OBTAINING THE METER MEMORY RESULT OF 57 MG/DL; CUSTOMER WAS NOT CONCERNED WITH THIS RESULT): (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1599983 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX HMN 50CT 24/CASE MG/DL ZY4347S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown