BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 7131890 · Received December 19, 2017

    Report

    Report Number
    1000113657-2017-02088
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    November 8, 2017
    Report Date
    December 19, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. RETURNED TEST STRIPS EVALUATED WITH DEFECT FOUND; RETURNED TEST STRIPS PRODUCE LOW READINGS AND BLACK CHEMISTRY OBSERVED. QC INVESTIGATION ON (B)(6) 2017 RESULTED IN DEFECT FOUND AND THE EVENT WAS DETERMINED TO BE REPORTABLE. FINAL ROOT CAUSE: RC- 003 OTHER ROOT CAUSE: BLACK CHEMISTRY DUE TO IMPROPER STORAGE. NOTE: MANUFACTURER CONTACTED CUSTOMER ON 12/6/2017 IN A FOLLOW-UP CALL IN ORDER TO ENSURE THAT THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN; CUSTOMER STATED THAT THE REPLACEMENT PRODUCT IS WORKING TO THEIR SATISFACTION AND THEY HAVE NOT HAD ANY MEDICAL INTERVENTION SINCE THE LAST CALL.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT OF E-5 ERROR: TEST STRIP ERROR. THE E-5 ERROR OCCURRED AS SOON AS THE BLOOD SAMPLE WAS ABSORBED. DURING THE CALL ON (B)(6) 2017, THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL INTERVENTION IS NOT REPORTED AT THE TIME OF THE CALL ON (B)(6) 2017 AS A RESULT OF THE METER'S READINGS. A BLOOD TEST WAS NOT PERFORMED DURING CALL ON (B)(6) 2017 AS CUSTOMER IS USING DISCONTINUED PRODUCTS. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/17/2019 AND OPEN VIAL DATE WAS UNDISCLOSED. CUSTOMER'S TEST STRIPS ARE NOT IMPACTED BY RECALL FOR BGM PQQ TEST STRIP. ADVERSE EVENT NOT REPORTED AT TIME OF CALL ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907989 TRUERESULT BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUERESULT PT2692

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR