BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 12907815 · Received December 1, 2021

    Report

    Report Number
    1000113657-2021-00754
    Event Type
    Malfunction
    Date Received
    December 1, 2021
    Date of Event
    November 4, 2021
    Report Date
    January 6, 2022
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 06-JAN-2022: 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. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-020: USER'S TEST STRIP HAD POOR STORAGE.

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. NOTE: MANUFACTURER CONTACTED CUSTOMER IN SEVERAL FOLLOW-UP CALLS TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

    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 159, 233, 112. 200 AND 165MG/DL. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 70-80MG/DL AND EXPECTED NON-FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 180-200MG/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 203MG/DL USING TRUE METRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 02/28/2023 AND OPEN VIAL DATE IS (B)(6)2021. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 159MG/DL, DATE: (B)(6) 2021, TIME: 8:04AM, FASTING. RESULT 2: 233MG/DL, DATE: (B)(6) 2021, TIME: 6:43PM, NON-FASTING. RESULT 3: 112MG/DL, DATE: (B)(6) 2021, TIME: 8:13AM, FASTING. RESULT 4: 200MG/DL, DATE: (B)(6) 2021, TIME: 6:46PM, NON-FASTING. RESULT 5: 165MG/DL, DATE: (B)(6) 2021, TIME: 7:48AM, FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1804293 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, SUNMARK TMX 50CTMG/DL MY4473S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown