BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 7735278 · Received July 31, 2018

    Report

    Report Number
    1000113657-2018-00809
    Event Type
    Malfunction
    Date Received
    July 31, 2018
    Date of Event
    June 16, 2016
    Report Date
    July 31, 2018
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT NUMBER: MW5063004. NOTIFICATION RECEIVED THI : (B)(6) 2018; FDA REPORT: (B)(6) 2016; DATE OF EVENT: (B)(6) 2016. FDA MEDWATCH REPORT FOUND DURING AN INTERNAL POST MARKET SURVEILLANCE REVIEW WHEN PERFORMING A MAUDE DATABASE SEARCH. NOTIFICATION REGARDING THE MW5063004 NEVER RECEIVED BY MANUFACTURER MOST LIKELY UNDERLYING ROOT CAUSE: MLC-101-USER USED THE WRONG STRIP. NOTE: EMAIL WAS SENT TO FDA ON (B)(6) 2018 TO OBTAIN ADDITIONAL PATIENT CONTACT INFORMATION REGARDING MEDWATCH MW5063004 TO FOLLOW UP WITH CUSTOMER. RESPOND RECEIVED ON (B)(6) 2018 STATING THAT UNFORTUNATELY, THEY WERE UNABLE TO RELEASE ANY FURTHER INFORMATION THAT PERTAINS TO THE REPORT IN QUESTION.

    Description of Event or Problem · 1

    FDA MEDWATCH FOUND DURING A POST MARKET SURVEILLANCE. CUSTOMER COMPLAINT DETAILS: PT USED TRUE RESULT METER WITH TRUE METRIX STRIPS (SAME MANUFACTURER). THE STRIP FIT THE MACHINE AND LOOKED LIKE IT WAS WORKING AS USUAL (THIS WAS WITNESSED BY FNP AND MD AS WELL) BUT RECEIVED FALSE READING OF 23. VERIFIED BG ON HOSPITAL METER AND IT WAS 448.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579435 TRUERESULT BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUERESULT N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY