BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX AIR

    MDR report key: 19187845 · Received April 25, 2024

    Report

    Report Number
    1000113657-2024-00184
    Event Type
    Malfunction
    Date Received
    April 25, 2024
    Date of Event
    March 29, 2024
    Report Date
    April 25, 2024
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT TESTED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-020: USER'S TEST STRIP HAD POOR STORAGE. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON (B)(6) 2024 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 AND ERRATIC) BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 121, 132, 131, 255 AND 140 MG/DL. CUSTOMER IS COMPARING RESULTS TO HER OTHER TRUE METRIX AIR METER: INTERNAL REPORT REFERENCE NUMBER (B)(4) . THE CUSTOMER¿S EXPECTED BLOOD GLUCOSE TEST RESULT RANGES ARE <100MG/DL AM FASTING AND BEFORE DINNER PM FASTING <110MG/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 BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION (BATHROOM). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 02/28/2025 AND TEST STRIPS WERE OPENED ONE MONTH AGO. THE CUSTOMER DID NOT HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 121 MG/DL DATE: 3/28 TIME: 3:03PM FASTING, RESULT 2: 132 MG/DL DATE:03/28 TIME: 9:23AM FASTING, RESULT 3: 131MG/DL DATE:03/28 TIME: 9:22AM FASTING, RESULT 4: 255 MG/DL DATE:3/23 TIME: 8:59AM FASTING, RESULT 5: 140 MG/DL DATE: 3/22 TIME: 8:45AM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1605448 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX HMN 50CT24/CASE MG/DL ZB5360S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown