BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 16242585 · Received January 25, 2023

    Report

    Report Number
    1000113657-2023-00040
    Event Type
    Malfunction
    Date Received
    January 25, 2023
    Date of Event
    January 3, 2023
    Report Date
    February 28, 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

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 28-FEB-2023: H6: UPDATED FDA¿S TYPE, FINDINGS AND CONCLUSIONS CODES. H10: METER WAS NOT RETURNED FOR EVALUATION. TEST STRIPS WERE NOT RETURNED FOR EVALUATION. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT TESTED WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). ADDITIONAL REPORT REFERENCE NUMBER (B)(4): SAME METER SERIAL NUMBER, DIFFERENT TEST STRIPS. METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-020: USER'S TEST STRIP HAD POOR STORAGE. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 18 JAN 2023 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 LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 231, 235, 161, 74 AND 178 MG/DL. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGES ARE 100-115 MG/DL AM FASTING AND 110-130 MG/DL PM FASTING. 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 NOT STORED ACCORDING TO SPECIFICATION (KITCHEN). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 03/24/2024 AND TEST STRIPS WERE OPENED NIGHT PRIOR TO 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 (TIME NOT SET): RESULT 1: 231 MG/DL, DATE: (B)(6), TIME: 3:44PM FASTING AM; RESULT 2: 235 MG/DL, DATE: (B)(6), TIME: 12:44PM NON-FASTING AM; RESULT 3: 161 MG/DL, DATE: (B)(6), TIME: 10:30AM FASTING PM; RESULT 4: 74 MG/DL, DATE: (B)(6), TIME: 2:50AM NON-FASTING PM; RESULT 5: 178 MG/DL, DATE: (B)(6), TIME: 12:48AM FASTING PM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568172 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX HMN 50CT24/CASE MG/DL ZA4911S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown