BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 5923238 · Received September 1, 2016

    Report

    Report Number
    1000113657-2016-01449
    Event Type
    Malfunction
    Date Received
    September 1, 2016
    Date of Event
    August 11, 2016
    Report Date
    September 1, 2016
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECT FOUND ON RETURNED METER;RETURNED TEST STRIPS PRODUCED HIGH READINGS ON 30 AND 75 LEVEL. DEFECT FOUND. R&D FINAL ROOT CAUSE INVESTIGATION HAS BEEN COMPLETED. THE ROOT CAUSE IS IMPROPER STORAGE AND HANDLING: STRIPS EXPOSED TO TEMPERATURE AND HUMIDITY OUTSIDE ITS TOLERANCE RANGE.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED 283, 231, 136, 220, 231MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 70 TO 120MG/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) 2016, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING) AND PRODUCED TEST RESULTS OF 194 AND 216 MG/DL USING TRUE METRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE AIR CONDITIONED DEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/17/2017 AND OPEN VIAL DATE IS (B)(6) 2016 THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572468 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MT1679

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY