BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 7048485 · Received November 21, 2017

    Report

    Report Number
    1000113657-2017-01981
    Event Type
    Malfunction
    Date Received
    November 21, 2017
    Date of Event
    October 31, 2017
    Report Date
    November 21, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292001797
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-20-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 TEST RESULTS FROM RESULTS OBTAINED OF 172, 182, 223, 153 AND 167 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 107 - 120 MG/DL. CUSTOMER STATED THE HE HAS BEEN OBTAINING THE HIGH RESULTS SINCE HE STARTED USING THE TEST STRIPS TWO - THREE WEEKS AGO. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT HE HAD GONE TO THE DOCTOR FOR HIS NORMAL VISIT AND TOLD THE DOCTOR ABOUT THE METER. THE DOCTOR HAD DONE BLOOD WORK; CUSTOMER COULD NOT REMEMBER WHAT THE RESULTS WERE BUT STATED THAT THE DOCTOR TOOK HIM OFF HIS HIGH DOSAGE OF METFORMIN SINCE HIS BLOOD WORK WAS GOOD. 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 AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/21/2019 AND OPEN VIAL DATE AT TIME OF CALL IS TWO - THREE WEEKS. CUSTOMER HAD THE CORRECT CODE CHIP IN THE METER. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (TIME NOT SET): RESULT 1: 172 MG/DL DATE: (B)(6) 2017TIME:1:18PM FASTING, RESULT 2 :182 MG/DL DATE: (B)(6) 2017TIME: 1:49PM FASTING, RESULT 3 :223 MG/DL DATE: (B)(6) 2017TIME:1:48PM FASTING, RESULT 4 :153 MG/DL DATE:(B)(6) 2017 TIME: 1:24PM FASTING, RESULT 5 :167 MG/DL DATE:(B)(6) 2017 TIME: 1:09PM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830952 TRUETRACK BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUETRACK RU5065 00021292001797

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR