BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 6533762 · Received May 1, 2017

    Report

    Report Number
    1000113657-2017-00762
    Event Type
    Malfunction
    Date Received
    May 1, 2017
    Date of Event
    April 6, 2017
    Report Date
    May 1, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292006075
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT RETURNED FOR EVALUATION. NO REPLACEMENT PRODUCT AT THIS TIME. PRODUCT IS WORKING AS INTENDED. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HEMATOCRIT OUTSIDE OF RANGE (B)(4). NOTE: UNABLE TO CONTACT THE CUSTOMER VIA TELEPHONE AT CALL BACKS ON 04/07/2017, 04/08/2017, 04/09/2017, 04/10/2017 AND 04/12/2017. PRODUCT NOTIFICATION LETTER UNABLE TO BE SENT DUE TO NO ADDRESS ON FILE FOR CUSTOMER. MANUFACTURER CONTACTED CUSTOMER ON (B)(6) 2017 IN A FOLLOW-UP CALL IN ORDER TO ENSURE THE CUSTOMER'S CONDITION SINCE THE INITIAL CALL; CUSTOMER'S CONDITION IMPROVED. NO MEDICAL ATTENTION REPORTED. PRODUCT IS WORKING PROPERLY. CUSTOMER IS SATISFIED.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR E-0 ERROR: INVALID HEMATOCRIT. THE E-0 ERROR OCCURED WITH MULTIPLE STRIPS. CUSTOMER HAS ANEMIA. CUSTOMER STATED HE IS NOT ON ANY ROUTINE TREATMENT AND HAS NOT BEEN DIAGNOSED WITH RENAL FAILURE. THE CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE WAS UNDISCLOSED. DURING THE CALL ON (B)(6) 2017, THE CUSTOMER STATED HE WAS HAVING A HEADACHE. DURING THE CALL ON (B)(6) 2017, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULT OF 204 MG/DL USING TRUEMETRIX METER. THE PRODUCT STORAGE WAS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/29/2018 AND OPEN VIAL DATE WAS UNKNOWN. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316424 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MT2180 00021292006075

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY