BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 5695027 · Received June 2, 2016

    Report

    Report Number
    1052693-2016-01048
    Event Type
    Malfunction
    Date Received
    June 2, 2016
    Date of Event
    May 12, 2016
    Report Date
    June 2, 2016
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT
    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. THE MOST LIKELY ROOT CAUSE OF TRUETEST PQQ-PD LOT PS2553 THAT GAVE E5 ERRORS IS DUE TO THE "AUTOCAL" SECTION WAS DAMAGED DURING MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD GLUCOSE TEST RESULTS AND E-6 ERROR; TEST STRIP ERROR. E-6 ERROR OCCURRED UPON INSERTION OF TEST STRIP. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REPORTED AT THE TIME OF THE CALL ON (B)(6) 2016 AS A RESULT OF THE METER'S READINGS. BLOOD TEST PERFORMED FASTING DURING CALL ON (B)(6) 2016 PRODUCED RESULT OF 117MG/DL AFTER BLOOD SAMPLE APPLIED TO TEST STRIP. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/30/2018 AND OPEN VIAL DATE IS NOT PROVIDED. REVIEWED METER MEMORY (B)(6). THE INITIAL E-6 WAS SOLVED VIA TRAINING. THE CUSTOMER STATED THAT HER RANGE IS NORMALLY BETWEEN 101-117MG AND HER DOCTOR WISHES FOR HER TO STAY BELOW 200MG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350741 TRUERESULT BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUERESULT PS2553

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY