BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JRESULTNET USING PROVUE DRIVER V1.5.3 OR LOWER

    MDR report key: 4085316 · Received August 22, 2014

    Report

    Report Number
    3007289202-2014-00001
    Event Type
    Malfunction
    Date Received
    August 22, 2014
    Date of Event
    July 29, 2014
    Report Date
    August 19, 2014
    Manufacturer
    DATA INNOVATIONS LLC
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER SUPPORT INCIDENT (B)(4) WAS SUBMITTED TO DATA INNOVATIONS NORTH AMERICA (DI) ON (B)(4) 2014 BY (B)(4) OF DI (CUSTOMER SERVICE REP) ON BEHALF OF (B)(6) OF (B)(6) HOSPITAL. (B)(6) REPORTED INTERMITTENT PROBLEMS WITH RESULTS SENT TO (B)(4) NOT MATCHING THOSE OF THE PRINTOUT ON THE PROVUE ANALYZER, AND THE RESULTS FOR 3 DIFFERENT PTS WERE COMBINED AND POSTED TO EACH OF THE 3 PAT'S RESULTS IN THE LABORATORY INFO SYSTEM (LIS) WHEN SENT FROM THE PROVUE ANALYZER. (B)(6) STATED THAT THE ISSUE ALWAYS INVOLVED A BATCH OR RESULTS WHERE A NUMBER OF THE RESULTS WERE CANCELLED PRIOR TO BEING TRANSMITTED TO JRESULTNET FROM THE PROVUE INSTRUMENT. (B)(6) STAFF DID NOT INTENTIONALLY CANCEL ANY OF THE RESULTS AND COULD NOT REPLICATE THE ISSUE. THERE WAS NO PT HARM REPORTED IN THIS INCIDENT. THE LABORATORY DISCOVERED THE ERRONEOUS RESULTS AND REPORTED THE ISSUE TO DATA INNOVATIONS LLC IN (B)(4) (PREVIOUSLY DAWNING TECHNOLOGIES, INC). POTENTIAL ISSUES WITH THE PROVUE DRIVER HAVE BEEN IDENTIFIED WHICH MAY CAUSE DATA TO BE MIS-ASSOCIATED WITH PT RESULTS UNDER A GIVEN SET OF CIRCUMSTANCES. THE USER ON THE PROVUE TRANSMITS THE SAME RESULTS TWICE BACK TO BACK BY CLICKING THE SEND TO HOST BUTTON TWICE. THE PROVUE SENDS TWO ASTM MESSAGES BACK TO BACK BEFORE ENDING TRANSMISSION (SENDING AN EOT CHARACTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508103 JRESULTNET USING PROVUE DRIVER V1.5.3 OR LOWER CALCULATOR/DATA PROCESSING MODULE JQP DATA INNOVATIONS LLC PROVUE.JRM VL.5.3

    Patients

    Seq Age Sex Outcome Treatment
    1