BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 7527404 · Received May 18, 2018

    Report

    Report Number
    1000113657-2018-00567
    Event Type
    Malfunction
    Date Received
    May 18, 2018
    Date of Event
    April 25, 2018
    Report Date
    May 18, 2018
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007829
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION. 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 ON (B)(6) 2018 IN A FOLLOW-UP CALL IN ORDER TO ENSURE THAT THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN; CUSTOMER DID RECIEVE THE REPLACEMENT METER BUT STATES THAT HE WILL CALL US BACK AT ANOHTER TIME. THEY DIDN'T REPORT ANY MEDICAL INTERVENTION OR SYMPTOMS SINCE THE LAST CALL. PRODUCT NOTIFICATION LETTER SENT TO CUSTOMER TO CONTACT CUSTOMER CARE.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 252, 223, 226, 362 AND 248 MG/DL. CUSTOMER ALSO STATED SHE HAD PERFORMED METER TO METER COMPARISON TEST AND OBTAINED 252 MG/DL USING TRUEMETRIX METER AND 183 MG/DL USING ANOTHER DEVICE. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 149 - 150 MG/DL. CUSTOMER STATED THAT SHE HAS BEEN HAVING THIS ISSUE FOR A WHILE AND THAT THE TRUEMETRIX IS A REPALCEMENT METER. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. CUSTOMER DECLINED TO PERFORM A BACK TO BACK BLOOD TEST DURING THE CALL ON (B)(6) 2018. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/31/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1:252MG/DL DATE: (B)(6) 2018 TIME:7:00PM FASTING; RESULT 2:223MG/DL DATE: (B)(6) 2018 TIME:535PM FASTING; RESULT 3:226MG/DL DATE: (B)(6) 2018 TIME:5;32PM FASTING; RESULT 4:362MG/DL DATE: (B)(6) 2018 TIME:12:56PM FASTING; RESULT 5:248MG/DL DATE:(B)(6)2018 TIME:9:00PM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369836 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MV2770 00021292007829

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR