BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 6830034 · Received August 30, 2017

    Report

    Report Number
    1000113657-2017-01638
    Event Type
    Malfunction
    Date Received
    August 30, 2017
    Date of Event
    August 17, 2017
    Report Date
    August 30, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007041
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    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: 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 332, 297 AND 198 MG/DL. THE CUSTOMER IS ALSO CONCERNED THAT THE RESULTS OBTAINED OF 332 AND 297 MG/DL ARE ERRATIC. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 155 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 AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/28/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: 198MG/DL (B)(6) 2017 07:24 AM FASTING:YES, 297MG/DL (B)(6) 2017 09:22 PM FASTING:YES, 332MG/DL (B)(6) 2017 09:21 PM FASTING:YES, 166MG/DL (B)(6) 2017 08:04 AM FASTING:YES, 166MG/DL (B)(6) 2017 10:06 PM FASTING:YES. MEMORY CONCERNS:CUSTOMER IS CONCERNED WITH 332, 297 AND 198MG/DL FASTING RESULTS. CUSTOMER IS ALSO CONCERNED ABOUT 332 AND 297MG/DL ERRATIC FASTING RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610618 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MU2414 00021292007041

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY