BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 17836427 · Received September 28, 2023

    Report

    Report Number
    1000113657-2023-00488
    Event Type
    Malfunction
    Date Received
    September 28, 2023
    Date of Event
    September 6, 2023
    Report Date
    October 19, 2023
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER WAS RETURNED - PRODUCT EVALUATION IN PROCESS. TEST STRIPS WERE NOT RETURNED FOR EVALUATION - CUSTOMER HAD RETURNED THE INCORRECT TEST STRIPS. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT TESTED WITHIN SPECIFICATIONS. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 20-SEP-2023 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED REPLACEMENT PRODUCTS RESOLVED INITIAL CONCERN.

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 19-OCT-2023: H3: WAS THE DEVICE EVALUATED BY THE MANUFACTURER. H6: UPDATED FDA¿S TYPE, FINDINGS AND CONCLUSIONS CODES. H10: TEST STRIPS WERE NOT RETURNED FOR EVALUATION - CUSTOMER HAD RETURNED THE INCORRECT TEST STRIPS. METER WAS RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND ON RETURNED METER. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-134: USER HAS LOW GLUCOSE VALUE.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR LOW AND HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 28, 62, 150, 166 AND 135 MG/DL. THE CUSTOMER¿S EXPECTED AM NON-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 BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULT OF 110 MG/DL USING TRUE METRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 12/22/2024 AND TEST STRIPS HAVE BEEN OPENED FOR TWO MONTHS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (CUSTOMER TOOK GLIPIZIDE PRIOR TO TESTING FOR RESULTS 1-4): RESULT 1: 28 MG/DL, DATE: (B)(6), TIME: 07:44 AM NON-FASTING. RESULT 2: 62 MG/DL, DATE: (B)(6), TIME: 06:36 PM NON-FASTING. RESULT 3: 150 MG/DL, DATE: (B)(6), TIME: 09:33 AM NON-FASTING. RESULT 4: 166 MG/DL, DATE: (B)(6), TIME: 11:23 AM NON-FASTING. RESULT 5: 135 MG/DL, DATE: (B)(6), TIME: 04:23 AM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2157793 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX 50CTMG/DL ZB5279S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown