BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNQUEST LABORATORY

    MDR report key: 11616238 · Received April 5, 2021

    Report

    Report Number
    2029302-2020-00001
    Event Type
    Malfunction
    Date Received
    April 5, 2021
    Date of Event
    October 28, 2020
    Report Date
    November 25, 2020
    Manufacturer
    SUNQUEST INFORMATION SYSTEMS
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    193 SITES HAVE BEEN NOTIFIED VIA PRODUCT SAFETY NOTICE (PSN) AND A CORRECTION WILL BE AVAILABLE IN SUNQUEST LABORATORY 7.0 AND ABOVE. THERE ARE 0 SITES THAT HAVE ALREADY BEEN CORRECTED. NO INSTANCES OF PATIENT HARM HAVE BEEN REPORTED AS A RESULT OF THIS ISSUE. THE ROOT CAUSE OF THIS PROBLEM IS THAT THE SUNQUEST INTERNAL CACH¿ CODING STANDARDS WERE NOT MET REGARDING SCOPING AND CLEANUP OF LOCAL VARIABLES BETWEEN ROUTINES. SUNQUEST INTERNAL STANDARD 'STD_401 MCACHE PROGRAMING STANDARDS' SPECIFIES TO ALWAYS USE THE 'NEW' COMMAND FOR THE VARIABLES INTRODUCED IN THE IN THE SUBROUTINES AND CACH¿ OBJECT METHODS. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    IN SUNQUEST LABORATORY ROLL AND SCROLL FUNCTIONS FOR ALL ONLINE ENTRY (OE, OEH, OEHS, OEM, OEO) PENDING TESTS MAY GET RESULTED ERRONEOUSLY. FOR THIS ISSUE TO OCCUR THE FOLLOWING CRITERIA AND USER ACTIONS MUST EXIST. CRITERIA FOR THIS ISSUE TO EXIST: THERE MUST BE AT LEAST TWO CUPS IN SEQUENCE BEING PROCESSED. THE TWO CUPS MUST HAVE AT LEAST ONE TEST CODE IN COMMON. THE TESTS IN THE FIRST CUP IN THE SEQUENCE CONTAIN RESULTS FROM THE INSTRUMENT. AT LEAST ONE CALCULATED TEST IN THE SECOND CUP IN SEQUENCE HAS NO RESULT FROM THE INSTRUMENT. A TEST THAT IS IMPACTED ON THE SECOND CUP IN SEQUENCE CONTAINS A USER DEFINED CALCULATION. BOTH OF THESE USER ACTIONS MUST OCCUR USER BEGINS MODIFICATION TO A TEST IN THE FIRST CUP IN SEQUENCE WITH THE RESULT BUT CANCELS MODIFICATION. RESULTS ARE THEN REJECTED FROM THE FIRST CUP. WHEN THE ABOVE CRITERIA ARE MET WITH THE REJECTED RESULT FROM THE FIRST CUP, THE RESULT ON THE SECOND CUP FROM THE TEST CODE IN COMMON WILL BE CARRIED OVER INTO ALL REMAINING PENDING TESTS THAT HAVE A USER-DEFINED CALCULATION. THIS WILL CONTINUE ON SUBSEQUENT CUPS THAT MEET THE CRITERIA UNTIL RESULTS FROM A CUP ARE ACCEPTED OR THE FUNCTION IS EXITED. THE ERROR ONLY OCCURS WHEN A CUP CONTAINS RESULTS FOR A PARTIAL LIST OF TESTS WITHIN THE ACCESSION (SMART NOT ENABLED) OR CONTAINER (SMART ENABLED) WHILE OTHERS REMAIN PENDING WITHIN ONLINE ENTRY. PLEASE NOTE THAT RESULTS FILED THROUGH AUTOMATIC FILING, WINDOWS-BASED RESULTS ENTRY, OR LARS DO NOT TRIGGER THE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514355 SUNQUEST LABORATORY LABORATORY JQP SUNQUEST INFORMATION SYSTEMS 6.4.1 AND ABOVE

    Patients

    Seq Age Sex Outcome Treatment
    1