BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 19358088 · Received May 21, 2024

    Report

    Report Number
    1000113657-2024-00227
    Event Type
    Malfunction
    Date Received
    May 21, 2024
    Date of Event
    April 28, 2024
    Report Date
    May 21, 2024
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    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 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-020: USER'S TEST STRIP HAD POOR STORAGE. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 13-MAY-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 BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 173, 334, 181 AND 165 MG/DL. CUSTOMER ALSO REPORTED THAT HE HAD OBTAINED A RESULT OF 354 MG/DL (UNDISCLOSED IF FASTING OR NON-FASTING) AND HE HAD ADMINISTERED 5 UNITS OF INSULIN. CUSTOMER STATED WHILE OUT WITH HIS FAMILY HE HAD ALMOST PASSED OUT. CUSTOMER STATED HE HAD EATEN AND FELT BETTER. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS BELOW 150 MG/DL. 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 02/24/2025 AND TEST STRIPS WERE OPEN 2 DAYS PRIOR TO THE CALL. 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 (DATE/TIME NOT SET): RESULT 1: 173 MG/DL DATE: 5/28/24 TIME: 6:27 PM FASTING RESULT 2: 334 MG/DL DATE: 5/28/24 TIME: 3:10 PM FASTING RESULT 3: 106 MG/DL DATE: 5/28/24 TIME: 2;16 AM FASTING RESULT 4: 181 MG/DL DATE: 5/28/24 TIME: 12:19 AM FASTING RESULT 5: 165 MG/DL DATE: 5/27/24 TIME: 1:00 PM FASTING AM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254081 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX WGN 100CT12/CS MG/DL #383569 ZB5341S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown