BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 9370335 · Received November 25, 2019

    Report

    Report Number
    1000113657-2019-10183
    Event Type
    Malfunction
    Date Received
    November 25, 2019
    Date of Event
    October 28, 2019
    Report Date
    May 2, 2020
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 02-MAY-2020: 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 AND PASSED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION AS OF (B)(6) 2019: ADDED MOST LIKELY UNDERLYING ROOT CAUSE. ADDED FOLLOW UP NOTE. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-55: USER HAD AN INACCURATE REFERENCE: COMPETITOR¿S METER: THE END USER IS COMPARING RESULTS OBTAINED FROM TRIVIDIA¿S BGM SYSTEM TO THE RESULTS FROM A COMPETITOR¿S BGM SYSTEM. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME. PRODUCT NOTIFICATION LETTER SENT TO CONTACT CUSTOMER CARE.

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR INVESTIGATION. MOST LIKELY UNDERLYING ROOT CAUSE.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 221, 204 AND 217 MG/DL. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 75 - 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. THE CUSTOMER DECLINED TO PERFORM A BACK TO BACK BLOOD TEST DURING THE CALL; CUSTOMER HAD TESTED PRIOR TO CALLING. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 09/30/2020 AND TEST STRIPS WERE OPENED THREE-FOUR WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 221MG/DL, DATE: 10/28, TIME: 4:10PM, FASTING. RESULT 2: 204MG/DL, DATE: 10/28, TIME: 3:55PM, FASTING. RESULT 3: 143MG/DL, DATE: 10/20, TIME: 9:22AM, FASTING. RESULT 4: 217MG/DL, DATE: 10/10, TIME: 5:21PM, FASTING. RESULT 5: 185MG/DL, DATE: 10/10 , TIME: 3:40AM, FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1165726 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX WGN 100CT12/CS MG/DL #383569 MW3247S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1