BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 20385989 · Received October 7, 2024

    Report

    Report Number
    1000113657-2024-00403
    Event Type
    Malfunction
    Date Received
    October 7, 2024
    Date of Event
    September 18, 2024
    Report Date
    October 7, 2024
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER WAS RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND ON RETURNED METER. TEST STRIPS WERE NOT RETURNED FOR EVALUATION - CUSTOMER HAD RETURNED AN EMPTY VIAL OF TEST STRIPS. 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 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 A FOLLOW-UP CALL ON 25-SEP-2024 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CAREGIVER WHO STATED SHE DID NOT RUN A BLOOD TEST WITH CUSTOMER, SHE IS SATISFIED WITH THE CONTROLS TESTING IN RANGE AND WILL RUN A BLOOD TEST WHEN THE CUSTOMER IS AVAILABLE.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH AND LOW BLOOD GLUCOSE TEST RESULTS. CAREGIVER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 375, 120, 159 AND 63 MG/DL. CAREGIVER STATED THE CUSTOMER STRUGGLES WITH LOW BLOOD SUGAR SO THE METER READING HIGH IS NOT NORMAL FOR HER. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90-100 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. DURING THE CALL, A BACK-TO-BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE MEDICINE CART IN THE FACILITY. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 09/30/2025 AND OPEN VIAL DATE IS 30 DAYS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (TIME NOT SET): RESULT 1: 93 MG/DL DATE: (B)(6)2024 TIME: 8:00AM FASTING AM. RESULT 2: 375 MG/DL DATE: (B)(6)2024 TIME: 8:AM FASTING AM. RESULT 3: 120 MG/DL DATE: (B)(6)2024 TIME: 7:00PM FASTING AM. RESULT 4: 159 MG/DL DATE: (B)(6)2024 TIME: 8:00AMFASTING AM. RESULT 5: 63 MG/DL DATE: (B)(6)2024 TIME: 7:00AM FASTING AM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246827 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX MEDIMEDI 50CT MG/DL ZC5620S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown