BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 8179728 · Received December 19, 2018

    Report

    Report Number
    1000113657-2018-01265
    Event Type
    Malfunction
    Date Received
    December 19, 2018
    Date of Event
    November 28, 2018
    Report Date
    December 19, 2018
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. TEST STRIP VIAL RETURNED WITH EXPIRED TEST STRIPS - UNABLE TO TEST. RETURNED METER EVALUATED WITH NO DEFECT FOUND. TEST STRIP VIAL RETURNED WITH ONE STRIP ONLY - UNABLE TO TEST. NOTE: MANUFACTURER CONTACTED CUSTOMER (SEVERAL ATTEMPTS) IN A FOLLOW-UP CALL TO ENSURE THAT THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH THE CUSTOMER AT THIS TIME. PRODUCT NOTIFICATION LETTER SENT TO CUSTOMER TO CONTACT CUSTOMER CARE.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. NURSE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF LO. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 149 - 235 MG/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 CALL ON (B)(6) 2018, A BACK-TO-BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/14/2018, AND OPEN VIAL DATE IS (B)(6) 2018; TEST STRIPS ARE EXPIRED. TEST STRIPS ARE NOT IMPACTED BY RECALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6) CALLER IS CALLING ON BEHALF OF ANOTHER PERSON STATES THE METER IS READING LO DISPLAY AND ONLY CONCERNED WITH THIS. CUSTOMER STATES THEIR NORMAL FASTING RANGE IS 149 MG/DL-235MG/DL FASTING.(B)(6) 2018, DISCONTINUED METFORMIN. STARTED BASAGLAR KWIK PEN STARTED (B)(6) 2018. THE CUSTOMER IS STORING THEIR METER AND TEST STRIPS IN THE KITCHEN; INFORMED THE CUSTOMER OF THE PROPERLY STORAGE RECOMMENDED BY THE MANUFACTURER. CUSTOMER ALSO INITIALLY FIRST OPENED VIAL SIX MONTHS AGO. INFORMED CUSTOMER OF PROPER TESTING TECHNIQUES. INFORMED CUSTOMER THAT TRUERESULT/TRUE2GO (PQQ) SYSTEMS HAVE BEEN DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020100 TRUERESULT BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUERESULT PS2491

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR