BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX AIR

    MDR report key: 20777582 · Received November 26, 2024

    Report

    Report Number
    1000113657-2024-00468
    Event Type
    Malfunction
    Date Received
    November 26, 2024
    Date of Event
    November 1, 2024
    Report Date
    November 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
    IA, 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: (B)(6): USER'S TEST STRIP HAD POOR STORAGE 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 · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. CUSTOMER ALSO STATED THAT THE METER GIVES 40-50 POINTS SPREAD. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 143, 166 AND 139 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80-100 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 TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 11/15/2025 AND OPEN VIAL DATE WAS NOT DISCLOSED. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION (KITCHEN). THE CUSTOMER DID HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY: LOT ZC5790S. DURING THE CALL, A BACK-TO-BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 158 MG/DL DATE: (B)(6)2024 TIME:1107AM FASTING. RESULT 2: 158 MG/DL DATE: (B)(6)2024 TIME: 806AM FASTING AM. RESULT 3: 165 MG/DL DATE: (B)(6)2024 TIME:804AM FASTING AM. RESULT 4: 159 MG/DL DATE: (B)(6)2024 TIME:644PM FASTING. RESULT 5: 160 MG/DL DATE: (B)(6)2024 TIME:1215PM FASTING. RESULT 6: 143 MG/DL DATE: (B)(6)2024TIME: 910AM FASTING. RESULT 7: 166 MG/DL DATE: (B)(6)2024 TIME:1025AM FASTING. RESULT 8: 139 MG/DL DATE: (B)(6)2024TIME: 129PM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1708167 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX 50CTMG/DL ZC5658S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown