BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 6313801 · Received February 9, 2017

    Report

    Report Number
    1000113657-2017-00244
    Event Type
    Malfunction
    Date Received
    February 9, 2017
    Date of Event
    January 15, 2017
    Report Date
    February 9, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292007690
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT # (B)(4). RETURNED METER EVALUATED WITH NO DEFECT FOUND. TEST STRIPS NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAD AN INACCURATE REFERENCE. TEST STRIP UDI# (B)(4).

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. NELLY, WIFE, IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 183, 148, 123, 146 AND 251MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 TO 140MG/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. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/25/2017 AND OPEN VIAL DATE IS LESS THAN ONE MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: THE 146MG/DL (B)(6) 2017 10:06 AM FASTING: YES, THE 102MG/DL (B)(6) 2017 05:54 PM FASTING: YES, THE 98MG/DL (B)(6) 2017 07:41 PM FASTING: YES, THE 148MG/DL (B)(6) 2017 06:15 AM FASTING: YES, THE 183MG/DL (B)(6) 2017 07:06 PM FASTING: YES. CUSTOMER STATES THAT ON THE (B)(6) HER HUSBAND RECEIVED A READING OF 251MG/DL FASTING AND THEN A READING OF 98MG/DL ON THE OTHER HAND . THE RESULT OF 251MG/DL WAS NOT FOUND IN THE METER'S MEMORY. CUSTOMER STATES THAT HER HUSBAND OBTAINED A RESULT OF 183MG/DL FASTING ON THE (B)(6) AND THEN RIGHT AFTER A READING OF 123MG/DL FASTING. THE RESULT OF 123MG/DL WAS ALSO NOT FOUND IN THE METERS MEMORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103356 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MT1857 00021292007690

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY