BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYLA V3.X CA

    MDR report key: 5959787 · Received September 19, 2016

    Report

    Report Number
    3002769706-2016-00340
    Event Type
    Malfunction
    Date Received
    September 19, 2016
    Report Date
    August 22, 2016
    Manufacturer
    BIOMERIEUX SA
    Product Code
    JQP
    PMA / PMN Number
    CL I, EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    A COMPLAINT WAS RECEIVED FROM A CUSTOMER WHO REPORTED THAT THE LIS SENT TWO (2) REQUESTS FOR TWO (2) DIFFERENT SPECIMENS (S1/S2) AND TWO (2) DIFFERENT PATIENTS (P1/P2), BUT MYLA DISPLAYED AND SENT THE RESULT OF SPECIMEN (S2) ASSOCIATED WITH THE WRONG PATIENT (P1/S2). THE CUSTOMER CONFIRMED THE LIS INTEGRATED THE RESULT WITH THE CORRECT PATIENT. AN INTERNAL BIOMERIEUX INVESTIGATION WAS PERFORMED. RESULTS ARE AS FOLLOWS: TWO (2) FILES WERE REVIEWED: - RAW TRACES.XML : EXTRACT OF RAW TRACES FROM REALTIME BCI LOG FILE. - TRACES EXPLANATIONS.XML : EXPLANATION OF THE REALTIME BCI LOG FILE. THE INVESTIGATION CONFIRMED THE ISSUE. BASED ON BCI REAL TIME TRACES BETWEEN LIS AND BCI, THE FOLLOWING WERE OBSERVED : - FIRST TRANSACTION INITIALIZED BY LIS : - START OF COMMUNICATION : AT "(B)(6) 2016 21:43:20.196 - <= <ENQ> " WITH <ENQ> TAG - REQUEST IS FOR P1 AND S1 - AT "(B)(6) 2016 21:43:20.427 - <= <ENQ>": THIS <ENQ> TAG IS NOT EXPECTED BECAUSE IT DIDN'T FOLLOW THE RS232 PROTOCOL - AFTER THIS NO EXPECTED TAG, WE CAN SEE THE NORMAL RS232 TAGS FOR END OF TRANSMISSION/COMMUNICATION - END OF COMMUNICATION : (B)(6) 2016 21:43:20.464 - <= <EOT> - BCI DIDN'T TRIGGER ANY ALARMS TO WARN THE CUSTOMER ABOUT THE PROTOCOL ISSUE. - THEN A TRANSACTION INITIATED BY BCI TO SEND A MYLA RESULT TO LIS : - START OF COMMUNICATION : AT (B)(6) 2016 21:43:20.594 - => <<ENQ> - END OF COMMUNICATION : (B)(6) 2016 21:43:21.460 - => <EOT> - NO PROTOCOL ISSUE FOR THIS RESULT - SECOND TRANSACTION INITIALIZED BY LIS : - AT (B)(6) 2016 21:43:21.506 - <= <ENQ> - REQUEST IS FOR P2 AND S2 - END OF COMMUNICATION : (B)(6) 2016 21:43:21.751 - <= <EOT> - NO PROTOCOL ISSUE FOR THIS SECOND REQUEST. BASED ON XML MESSAGES SENT BY BCI TO MYLA, OBSERVATION WAS: - BCI HAD SENT TWO (2) MESSAGES TO MYLA - FIRST REQUEST : P1 ASSOCIATED TO S1 - SECOND REQUEST : P1 ASSOCIATED TO S2 BECAUSE OF THE RS232 PROTOCOL ISSUE, BCI MEMORY BUFFERS WERE NOT FLUSHED BETWEEN THE FIRST REQUEST AND THE SECOND REQUEST. CONSEQUENCE : THE TWO (2) REQUESTS WERE MERGED IN A SAME MESSAGE. BCI DIDN'T MANAGE THIS MERGE MESSAGE AS EXPECTED : - FIRST XML MESSAGE PRODUCT BY BCI (BASED ON MERGED MESSAGES) AND SENT TO MYLA WAS CORRECT FOR P1 LINKED TO S1 - SECOND XML MESSAGE PRODUCT BY BCI (BASED ON MERGED MESSAGES) AND SENT TO MYLA WAS NOT CORRECT FOR P1 LINKED TO S2 ADDITIONAL INFORMATION: LOGS WERE ANALYZED BEFORE AND AFTER THE COMMUNICATION ISSUE. NO OTHER OCCURRENCE WAS HIGHLIGHTED. HOWEVER, FIVE (5) MINUTES BEFORE THE ISSUE, THE LIS NEVER ANSWERED BY <ACK> OR <NAK> TO A BCI OPEN SESSION REQUEST DATED "(B)(6) 2016 21:38:04.361 - => <ENQ>". MOREOVER, LIS SENT AN OPEN SESSION REQUEST THREE (3) SECONDS LATER: (B)(6) 2016 21:38:07.231 - <= <ENQ> THE MISSING <ACK> OR <NAK> FROM LIS IS AN ANOTHER NOT CONFORM RS232 PROTOCOL. ROOT CAUSE : INVESTIGATION SHOW THAT THE LIS REQUEST MESSAGES WERE NOT MANAGED ACCORDINGLY TO THE RS232 PROTOCOL SPECIFICATION. PROTOCOL DISCREPANCIES: - MISSING <ACK> OR <NAK> TO ANSWER BCI OPEN SESSION REQUEST AT (B)(6) 2016 21:38:07.231 - REPLACED BY LIS OPEN SESSION REQUEST <ENQ> - A NEW SESSION WAS REQUESTED BY LIS (ENQ SENT AT (B)(6) 2016 21:43:20.427 ) WHERE PREVIOUS SESSION WAS NOT CLOSED (MISSING <EOT>) SO, THE MAIN ROOT CAUSE OF ISSUE COMES FROM THE LIS. RECOMMENDATION IS FOR CUSTOMER TO CORRECT THE COMMUNICATION PROTOCOL IN LIS WITH HELP OF LEVEL1 AND LIS PROVIDER. INVESTIGATION ALSO INDICATED THE BCI DID NOT REJECT THE MESSAGE AND DID NOT WARN THE USER WITH AN ERROR. BCI MANAGED BOTH MESSAGES INCORRECTLY. CONSEQUENTLY, THE LIS REQUESTS WERE SENT TO MYLA WITH WRONG SPECIMEN/PATIENT ASSOCIATION.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) CONTACTED BIOMERIEUX TO REPORT AN OCCURRENCE OF RESULTS ASSIGNED TO THE INCORRECT PATIENT IN ASSOCIATION WITH THE MYLA SERVER. THE SAMPLE ID IS (B)(6). THE CORRECT PATIENT ID IS (B)(6). THE RESULTS FOR SAMPLE (B)(6) (PATIENT ID (B)(6)) WERE INADVERTENTLY ASSIGNED TO PATIENT ID (B)(6). THE ERRONEOUS LINK WAS CONFIRMED VIA VILINK BY GLOBAL CUSTOMER SERVICE. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR TREATING PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. LABORATORY PERSONNEL IDENTIFIED THE DISCREPANCY PRIOR TO UPLOADING THE RESULTS. BIOMERIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612644 MYLA V3.X CA MYLA V3.X CA JQP BIOMERIEUX SA

    Patients

    Seq Age Sex Outcome Treatment
    1