BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 6481590 · Received April 11, 2017

    Report

    Report Number
    1000113657-2017-00645
    Event Type
    Malfunction
    Date Received
    April 11, 2017
    Date of Event
    March 16, 2017
    Report Date
    April 19, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00041220001286
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. TEST STRIPS NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER'S TEST STRIP HAD POOR STORAGE (KITCHEN). (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER'S TEST STRIP HAD POOR STORAGE (KITCHEN). (B)(4).

    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 243 AND 289 MG/DL. THE CUSTOMER WAS ALSO CONCERNED THAT THE RESULTS WERE ERRATIC. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 70 - 129 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 ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/29/2018 AND OPEN VIAL DATE IS (B)(6) 2017. CUSTOMER STATED SHE TESTS FOUR TIMES A DAY. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (TIME NOT SET): (B)(6). MEMORY CONCERNS: CUSTOMER IS CONCERN WITH THE RESULTS OF (B)(6) 2017. CUSTOMER STATES THAT HER SUGAR WAS DOING GOOD. CUSTOMER STATES THAT SHE RUN A BLOOD TEST AND GOT 289/243/278 MG/DL .CUSTOMER HAVE ONLY BEEN USING THIS METER SINCE (B)(6) 2017.

    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 243 AND 289 MG/DL. THE CUSTOMER WAS ALSO CONCERNED THAT THE RESULTS WERE ERRATIC. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 70 - 129 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 ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/29/2018 AND OPEN VIAL DATE IS (B)(6) 2017. CUSTOMER STATED SHE TESTS FOUR TIMES A DAY. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (TIME NOT SET): (B)(6). CUSTOMER STATES THAT HER SUGAR WAS DOING GOOD. CUSTOMER STATES THAT SHE RUN A BLOOD TEST AND GOT 289/243/278 MG/DL .CUSTOMER HAVE ONLY BEEN USING THIS METER SINCE (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261892 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MT1987 00041220001286

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY