BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 6748892 · Received July 27, 2017

    Report

    Report Number
    1000113657-2017-01493
    Event Type
    Malfunction
    Date Received
    July 27, 2017
    Date of Event
    July 6, 2017
    Report Date
    July 27, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) MEDWATCH REPORT: MW5070590. SINCE CUSTOMER WAS NOT CONTACTED, PRODUCT NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE : (B)(4) - USER HAD POOR TECHNIQUE NOTE: MANUFACTURER TRY TO CONTACT CUSTOMER (SEVERAL ATTEMPTS) IN A FOLLOW-UP CALL IN ORDER TO OBTAIN MORE INFORMATION ABOUT THE COMPLAINT - UNABLE TO ESTABLISH CONTACT WITH THE CUSTOMER AT THIS TIME. MANUFACTURER'S CUSTOMER DATABASE REVIEWED UNABLE TO LOCATE ANY MATCHING CUSTOMER NAME OR CONTACT.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT DETAILS : I AM A TYPE 2 DIABETIC, I TEST FOR GLUCOSE LEVELS USING THE TRUE METRIX STRIPS MANUFACTURED BY TRIVIDIA HEATH. THE TEST LEVEL VARIES CONSIDERABLY MORE THAN THE STATED PERCENTAGE IN THE PACKAGE INSERT. TODAY THE LEVELS TESTED WITHIN MINUTES WERE 203, 282, 212, 246. THESE LEVELS DICTATE THE AMOUNT OF INSULIN I TAKE AND COULD RESULT IN AN OVERDOSE. I HAVE TESTED MULTIPLE TIMES ON VARIOUS OTHER DAYS WITH SIMILAR RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527098 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR