BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA SOLUTION

    MDR report key: 9974573 · Received April 17, 2020

    Report

    Report Number
    2432235-2020-00275
    Event Type
    Malfunction
    Date Received
    April 17, 2020
    Date of Event
    December 18, 2019
    Report Date
    October 14, 2020
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    UDI-DI
    00630414002163
    PMA / PMN Number
    K151767
    Removal / Correction Number
    2432235-03/06/2020-006-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL MDR 2432235-2020-00275 WAS FILED ON 17-APR-2020. SUPPLEMENTAL MDR 2432235-2020-00275_S1 WAS FILED ON 17-APR-2020. CORRECTED INFORMATION (14-OCT-2020): THE INITIAL MDR, FILED 17-APR-2020, INDICATED THE DATE RECEIVED BY MANUFACTURER (SECTION G4 AT THAT TIME) WAS 18-DEC-2019. THE FIRST SUPPLEMENTAL MDR, FILED 17-APR-2020, CORRECTED THE DATE RECEIVED BY MANUFACTURER (SECTION G4 AT THAT TIME) TO 17-APR-2020. SIEMENS HAS REVIEWED ITS RECORDS RELATED TO THE INITIAL AND SUPPLEMENTAL MDR FILINGS REFERENCED ABOVE AND DETERMINED THAT THE ACTUAL DATE RECEIVED BY MANUFACTURER WAS 13-APR-2020. THE DATE RECEIVED BY MANUFACTURER WAS DETERMINED FROM AN INVESTIGATION UPDATE BY THE SIEMENS GLOBAL ENGINEERING ORGANIZATION (GEO) SOFTWARE (SW) TEAM THAT FOUND THIS ISSUE IS RELATED TO THE FIELD ACTION ASW20-03, AS DOCUMENTED IN SECTION H10 OF THE INITIAL MDR. THIS MDR 2432235-2020-00275_S2 IS FILED TO PROVIDE THE CORRECT DATE RECEIVED BY MANUFACTURER OF 13-APR-2020.

    Additional Manufacturer Narrative · 0

    THE INITIAL MDR 2432235-2020-00275 WAS FILED ON 17-APR-2020 CORRECTED INFORMATION (17-APR-2020): THE CUSTOMER CONTACTED SIEMENS TO REPORT THAT A DISCORDANT, FALSELY DEPRESSED LACTATE DEHYDROGENASE (LDLP) TEST RESULT WAS OBTAINED FROM AN ATELLICA CH 930 INSTRUMENT. SIEMENS HEALTHCARE DIAGNOSTICS INVESTIGATED THIS ISSUE REGARDING THE ATELLICA CH 930 ANALYZERS. SIEMENS DETERMINED THAT IF AN OPERATOR EDITS TEST DEFINITION (TDEF) PARAMETERS FOR AN ASSAY WITHOUT "SAVING" THE CHANGES USING THE STEPS DOCUMENTED IN THE ONLINE HELP, AND THE OPERATOR ABRUPTLY SELECTS ANOTHER ASSAY TO EDIT, THERE IS A POTENTIAL FOR SOME OF THE EDITED PARAMETERS OF THE ORIGINAL ASSAY TO BE OVERWRITTEN BY SETTINGS OF THE NEWLY SELECTED ASSAY. THIS OCCURS IF THE "SAVE" BUTTON ON THE DIALOG BOX IS DISPLAYED AFTER THE SELECTION OF THE NEW ASSAY. IF AN OVERWRITE OF SETTINGS OCCURS, IT CAN IMPACT SOME, OR ALL, OF THE TDEF PARAMETERS ON THE DISPLAY AND POTENTIALLY AFFECT RESULTS FOR THE AFFECTED ASSAY. THE PROBABILITY OF THIS ISSUE OCCURRING IS EXTREMELY LOW AND REQUIRES A SPECIFIC TIMING WINDOW. STARTING (B)(6) 2020, AN URGENT MEDICAL DEVICE CORRECTION (UMDC) ASW20-03.A.US WAS SENT TO US CUSTOMERS AND AN URGENT FIELD SAFETY NOTICE (UFSN) ASW20-03.A.OUS WAS SENT TO OUTSIDE THE US (OUS) CUSTOMERS IN FEBRUARY OF 2020. THE UMDC AND UFSN EXPLAIN THE BEHAVIOR DESCRIBED ABOVE AND REQUEST FOR CUSTOMERS TO FOLLOW THE INSTRUCTIONS OUTLINED IN THE "EDITING ASSAY IDENTIFICATION PARAMETERS IN CH TEST DEFINITION" SECTION OF THE ATELLICA SOLUTION ONLINE HELP 1.20. THE UMDC AND UFSN INDICATE THAT EACH TDEF MUST BE SAVED USING THE "SAVE" BUTTON ON THE CH TEST DEFINITION SCREEN BEFORE MODIFICATIONS ON ANOTHER ASSAY'S TDEF ARE INITIATED AND ADVISE CUSTOMERS TO VERIFY THAT QUALITY CONTROL RESULTS ARE NOT AFFECTED, AND THAT RESULTS, UNITS, AND FLAGS ARE CORRECTLY REPORTED FOR ANY TDEF THAT HAS BEEN UPDATED BEFORE RUNNING PATIENT SAMPLES. ADDITIONALLY, THE UMDC AND UFSN RECOMMEND THAT CUSTOMER ENSURE ALL REAGENT PACKS HAVE VALID CALIBRATIONS BEFORE RUNNING PATIENT SAMPLES. THE UMDC AND UFSN DELINEATE THAT SOFTWARE IS BEING DEVELOPED TO RESOLVE THE BEHAVIOR. TO DATE, THERE ARE NO ALLEGATIONS OF INJURY DUE TO THIS BEHAVIOR.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT SIEMENS TO REPORT THAT A DISCORDANT, FALSELY DEPRESSED LACTATE DEHYDROGENASE (LDLP) TEST RESULT WAS OBTAINED FROM AN ATELLICA CH 930 INSTRUMENT. THE INITIAL RESULT WAS FLAGGED AS "E527: ABOVE MANUFACTURER'S ASSAY RANGE" AND "E708: ABOVE MANUFACTURER LIMIT". THE SAMPLE WAS NOT AUTO-DILUTED AND REPEATED AS EXPECTED BY THE INSTRUMENT. SIEMENS HEALTHCARE DIAGNOSTICS INVESTIGATED THIS ISSUE REGARDING THE ATELLICA CH 930 ANALYZERS. SIEMENS DETERMINED THAT IF AN OPERATOR EDITS TEST DEFINITION (TDEF) PARAMETERS FOR AN ASSAY WITHOUT "SAVING" THE CHANGES USING THE STEPS DOCUMENTED IN THE ONLINE HELP, AND THE OPERATOR ABRUPTLY SELECTS ANOTHER ASSAY TO EDIT, THERE IS A POTENTIAL FOR SOME OF THE EDITED PARAMETERS OF THE ORIGINAL ASSAY TO BE OVERWRITTEN BY SETTINGS OF THE NEWLY SELECTED ASSAY. THIS OCCURS IF THE "SAVE" BUTTON ON THE DIALOG BOX IS DISPLAYED AFTER THE SELECTION OF THE NEW ASSAY. IF AN OVERWRITE OF SETTINGS OCCURS, IT CAN IMPACT SOME, OR ALL, OF THE TDEF PARAMETERS ON THE DISPLAY AND POTENTIALLY AFFECT RESULTS FOR THE AFFECTED ASSAY. THE PROBABILITY OF THIS ISSUE OCCURRING IS EXTREMELY LOW AND REQUIRES A SPECIFIC TIMING WINDOW. STARTING 27-FEB-2020, AN URGENT MEDICAL DEVICE CORRECTION (UMDC) ASW20-03.A.US WAS SENT TO US CUSTOMERS AND AN URGENT FIELD SAFETY NOTICE (UFSN) ASW20-03.A.OUS WAS SENT TO OUTSIDE THE US (OUS) CUSTOMERS IN FEBRUARY OF 2020. THE UMDC AND UFSN EXPLAIN THE BEHAVIOR DESCRIBED ABOVE AND REQUEST FOR CUSTOMERS TO FOLLOW THE INSTRUCTIONS OUTLINED IN THE "EDITING ASSAY IDENTIFICATION PARAMETERS IN CH TEST DEFINITION" SECTION OF THE ATELLICA SOLUTION ONLINE HELP 1.20. THE UMDC AND UFSN INDICATE THAT EACH TDEF MUST BE SAVED USING THE "SAVE" BUTTON ON THE CH TEST DEFINITION SCREEN BEFORE MODIFICATIONS ON ANOTHER ASSAY'S TDEF ARE INITIATED AND ADVISE CUSTOMERS TO VERIFY THAT QUALITY CONTROL RESULTS ARE NOT AFFECTED, AND THAT RESULTS, UNITS, AND FLAGS ARE CORRECTLY REPORTED FOR ANY TDEF THAT HAS BEEN UPDATED BEFORE RUNNING PATIENT SAMPLES. ADDITIONALLY, THE UMDC AND UFSN RECOMMEND THAT CUSTOMER ENSURE ALL REAGENT PACKS HAVE VALID CALIBRATIONS BEFORE RUNNING PATIENT SAMPLES. THE UMDC AND UFSN DELINEATE THAT SOFTWARE IS BEING DEVELOPED TO RESOLVE THE BEHAVIOR. TO DATE, THERE ARE NO ALLEGATIONS OF INJURY DUE TO THIS BEHAVIOR.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY DEPRESSED LACTATE DEHYDROGENASE (LDLP) TEST RESULT WAS OBTAINED FROM AN ATELLICA CH 930 INSTRUMENT. THE INITIAL RESULT WAS FLAGGED AS "E527: ABOVE MANUFACTURER'S ASSAY RANGE AND "E708: ABOVE MANUFACTURER LIMIT". THE SAMPLE WAS NOT AUTO-DILUTED AND REPEATED AS EXPECTED BY THE INSTRUMENT. IT IS UNKNOWN IF THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED ON AN ALTERNATE ATELLICA CH 930 INSTRUMENT GIVING A HIGHER TEST RESULT. IT IS UNKNOWN IF THE REPEAT RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438145 ATELLICA SOLUTION ATELICA SOLUTION JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH 930 00630414002163

    Patients

    Seq Age Sex Outcome Treatment
    1