BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE2GO

    MDR report key: 5530047 · Received March 28, 2016

    Report

    Report Number
    1052693-2016-00615
    Event Type
    Malfunction
    Date Received
    March 28, 2016
    Date of Event
    February 29, 2016
    Report Date
    March 28, 2016
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080710
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT DOES NOT RETURNED FOR EVALUATION YET. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAD AN INACCURATE REFERENCE OR/AN USER HAD HIGH GLUCOSE LEVEL. MANUFACTURER CONTACTED CUSTOMER WITHIN 24 HOUR PHONE CALL;CUSTOMER REPORTED WAS AT THE DOCTOR'S OFFICE FOR CHECKING GLUCOSE LEVEL WITH DOCTOR'S OFFICE METER, THE RESULT OBTAINED IS 550MG/DL AFTER TESTED WITH TRUE2GO METER OBTAINING RESULTS OF 472MG/DL WHICH IS WITHIN 20% ACCURATE COMPARE DOCTOR'S OFFICE LAB RESULT.PHYSICIAN INJECTED EXTRA DOSIS OF INSULIN,SINCE CUSTOMER IS INSULIN DEPEND TO LOW THE GLUCOSE LEVELS TO AN ACCEPTABLE LEVEL;CUSTOMER CONSIDER IS NOTHING WRONG WITH THE TRE2GO METER,CUSTOMER IS SATISFIED WITH THE METER PERFORMANCE.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100MG/DL TO 200MG/DL. THE CUSTOMER REPORTED SYMPTOMS OF HYPERGLYCEMIA. THE CUSTOMER CONSULTED PHYSICIAN AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PHYSICIAN ADDED AN EXTRA DOSE OF INSULIN FOR THE CUSTOMER.THE CUSTOMER IS CURRENTLY TAKING INSULIN TO MANAGE DIABETES. THE CUSTOMER IS COMPARING THE BLOOD GLUCOSE TEST RESULTS FROM TRUE2GO METER TO PHYSICIAN METER. ON (B)(6) 2016, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 547 MG/DL. THEN, THE CUSTOMER WENT TO THE PHYSICIAN'S OFFICE A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 550 MG/DL USING PHYSICIAN'S METER AND 472 MG/DL USING TRUE2GO METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION.THE TEST STRIP LOT # NOT PROVIDED AND OPEN VIAL DATE IS WITHIN 120 DAYS. THE METER MEMORY WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184490 TRUE2GO BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUE2GO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR