BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIPOC DATA MANAGEMENT SYSTEM

    MDR report key: 7759238 · Received August 7, 2018

    Report

    Report Number
    3002637618-2018-00092
    Event Type
    Malfunction
    Date Received
    August 7, 2018
    Date of Event
    July 12, 2018
    Report Date
    August 8, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JQP
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO EVENT DESCRIPTION.

    Description of Event or Problem · 0

    A NON-SIEMENS COAGULATION MONITORING INSTRUMENT CONNECTED TO UNIPOC BY THE MIDDLEWARE DNOTE (SIEMENS-DISTRIBUTED) DISPLAYED AN ACT+ RESULT OF ">1005" ON THE INSTRUMENT DISPLAY (AN OUT-OF-RANGE HIGH VALUE), HOWEVER THE INSTRUMENT TRANSMITTED THE RESULT "0" TO DNOTE AND AN INDICATOR THAT THE RESULT WAS "NORMAL". DNOTE THEN PASSED THE RESULT TO UNIPOC, WHICH DISPLAYED THE "0" RESULT TO THE CUSTOMER. A MESSAGE "ERROR: OUT OF RANGE-HI" WAS PRESENT IN THE NTE (COMMENTS) FIELD. IT HAS BEEN CONFIRMED THAT DNOTE OPERATED AS INTENDED. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    DNOTE AND UNIPOC ARE RECEIVING AND DISPLAYING THE DATA AS SENT BY THE INSTRUMENT. SIEMENS HAS CONTACTED THE INSTRUMENT MANUFACTURER TO REPORT THIS ISSUE.

    Description of Event or Problem · 1

    A NON-SIEMENS COAGULATION MONITORING INSTRUMENT CONNECTED TO UNIPOC BY THE MIDDLEWARE DNOTE (SIEMENS-DISTRIBUTED) DISPLAYED AN ACT+ RESULT OF ">1005" ON THE INSTRUMENT DISPLAY (AN OUT-OF-RANGE HIGH VALUE), HOWEVER THE INSTRUMENT TRANSMITTED THE RESULT "0" TO DNOTE AND AN INDICATOR THAT THE RESULT WAS "NORMAL". DNOTE THEN PASSED THE RESULT TO UNIPOC, WHICH DISPLAYED THE "0" RESULT TO THE CUSTOMER. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598962 UNIPOC DATA MANAGEMENT SYSTEM UNIPOC & DNOTE JQP SIEMENS HEALTHCARE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1