BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 19771684 · Received July 18, 2024

    Report

    Report Number
    1000113657-2024-00298
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Date of Event
    June 26, 2024
    Report Date
    July 18, 2024
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT TESTED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-062: USER HAD POOR TECHNIQUE. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 03-JUL-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 116, 119, 142, 114 AND 132 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT IS BELOW 80 MG/DL AND EXPECTED PM FASTING BLOOD GLUCOSE TEST RESULT IS BELOW 120 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 PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 100 MG/DL AND 96 MG/DL USING TRUE METRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE OFFICE. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 09/30/2025 AND TEST STRIPS WERE OPENED 3 WEEKS PRIOR TO THE CALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 114 MG/DL DATE: 6/26/2024 TIME: 9:29 AM FASTING RESULT 2: 132 MG/DL DATE: 6/26/2024 TIME: 9:26 AM FASTING RESULT 3: 119 MG/DL DATE: 6/26/2024 TIME: 9:26 AM FASTING RESULT 4: 137 MG/DL DATE: 6/26/2024 TIME: 9:16 AM FASTING RESULT 5: 125 MG/DL DATE: 6/26/2024 TIME: 9:15 AM FASTING RESULT 6: 116 MG/DL DATE: 6/25/2024 TIME: 8:36 PM FASTING RESULT 7: 119 MG/DL DATE: 6/25/2024 TIME: 8:36 PM FASTING RESULT 8: 142 MG/DL DATE: 6/25/2024 TIME: 8:34 PM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1551384 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX SGC 100CT12/CS MG/DL ZC5615S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown