BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 6968157 · Received October 23, 2017

    Report

    Report Number
    1000113657-2017-01849
    Event Type
    Malfunction
    Date Received
    October 23, 2017
    Date of Event
    September 28, 2017
    Report Date
    October 23, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-58-USER HAD AN INACCURATE REFERENCE: SELF: THE PERSON IS USING THEMSELVES AS THE REFERENCE OR HOW THEY FEEL AT THE TIME THEY RUN THE BLOOD TEST. NOTE: CONFIRMATION EMAIL RECEIVED ON 09/21/2017 FROM ANDREA ARTURA CONFIRMING NEW REPLACEMENT PRODUCTS WERE SENT TO CUSTOMER AND ARE WORKING AS INTENDED AT THIS TIME. NO DETAILS ON SERIAL NUMBER OR STRIP LOT NUMBER PROVIDED. NO FURTHER ACTION REQUIRED AT THIS TIME. MANUFACTURER ATTEMPTED TO OBTAIN REPORTER'S INFORMATION ON SEVERAL OCCASIONS IN ORDER TO CLARIFY THE EVENT DESCRIPTION AND FIND OUT THE SERIOUS (IMPORTANT MEDICAL EVENT) OUTCOME WHILE PRODUCT WAS USED, IN ADDITION OF CUSTOMER'S CONDITION. UNABLE TO ESTABLISH CONTACT WITH THE CUSTOMER AT THIS TIME. NO ADDITIONAL INFORMATION WAS OBTAINED.

    Description of Event or Problem · 1

    DATE OF INCIDENT REPORTED TO ARRIVA: 9/21/2017, ACTUAL COMPLAINT DATE: 9/20/2017, DATE REPORTED TO THI- 9/27/2017. CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. ARRIVA MEDICAL IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS UNDISCLOSED AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER WAS GETTING HIGH RESULTS FROM THE METER AND TOO MUCH INSULIN TAKEN AS A RESULT. THE CUSTOMER NEEDED MEDICAL ATTENTION AND WAS HOSPITALIZED. LIMITED DETAILS REGARDING THE EVENT. NO INFORMATION ON THE SERIAL NUMBER, STRIP LOT# PROVIDED. UNABLE TO OBTAIN MORE INFORMATION ABOUT THE PRODUCT AND THE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748580 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Hospitalization