BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUBALANCE

    MDR report key: 5876831 · Received August 15, 2016

    Report

    Report Number
    1000113657-2016-01350
    Event Type
    Malfunction
    Date Received
    August 15, 2016
    Date of Event
    July 23, 2016
    Report Date
    August 15, 2016
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K090495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECT FOUND ON RETURNED METER. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAD AN INACCURATE REFERENCE.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM BACK TO BACK BLOOD TEST OF 254 AND 340MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 114-170 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 THE CALL ON (B)(6) 2016, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 156 AND 192MG/DL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 8/31/2018 AND OPEN VIAL DATE IS (B)(6) 2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). MEMORY CONCERNS: THE CUSTOMER IS CONCERNED WITH THE RESULT OF 231, 187, 340 AND 254MG/DL IN THE METER'S MEMORY. THE CUSTOMER STATED THAT IS TESTING ON FASTING MODE. THE CUSTOMER IS CONCERNED THAT DID THE TESTS A FEW MINUTES APART AND THE RESULTS AND THE VARIANCE WAS WIDE. MANUFACTURER RECOMMENDED NO TEST IMMEDIATELY AFTER ONE FIRST TIME. THE CUSTOMER HAS NOT HAD ANY CHANGES IN THE DIET. CUSTOMER EXPRESSED CONCERN WITH THE BACK TO BACK BLOOD TEST THAT WAS TAKEN. CUSTOMER EDUCATED ABOUT THE ACCEPTABLE VARIANCE WITH A BACK TO BACK TEST IS 20%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529350 TRUBALANCE BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUBALANCE BT4885

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR