BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 6727838 · Received July 20, 2017

    Report

    Report Number
    1000113657-2017-01448
    Event Type
    Malfunction
    Date Received
    July 20, 2017
    Date of Event
    June 28, 2017
    Report Date
    July 20, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00096295126655
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) (B)(4). PRODUCT NOT RETURNED FOR EVALUATION. NO METER REPLACED AT THIS TIME. REPLACED TEST STRIPS ONLY. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: MLC-20 USER'S TEST STRIP HAD POOR STORAGE.(BASEMENT). TEST STRIP (B)(4). NOTE: UNABLE TO CONTACT THE CUSTOMER VIA TELEPHONE AT CALL BACKS ON 06/29/2017,06/30/2017 AND 07/03/2017. PRODUCT NOTIFICATION LETTER SENT TO CUSTOMER TO CONTACT CUSTOMER CARE. (B)(4).

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR E-3 ERROR: USED TEST STRIP, TEST STRIP OUTSIDE OF VIAL TOO LONG, SAMPLE ON TOP OF TEST STRIP. SON IS CALLING ON BEHALF OF THE CUSTOMER. THE E-3 ERROR OCCURRED WHEN THE BLOOD SAMPLE WAS ABSORBED. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 200 - 215 MG/DL. DURING THE CALL ON (B)(6) 2017, THE CUSTOMER REPORTED FEELING HUNGRY, BODY FEELING WARM AND FEELING DRY MOUTH. CUSTOMER DENIED THE NEED FOR MEDICAL ATTENTION AT THE TIME OF THE CALL. DURING THE CALL ON (B)(6) 2017, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 231 MG/DL USING TRUEMETRIX METER. CUSTOMER WAS COMFORTABLE WITH THE RESULT. CUSTOMER STORES STRIPS IN THE BASEMENT. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/14/2018 AND OPEN VIAL DATE WAS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507899 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MT1877 00096295126655

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR