BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 3602640 · Received January 31, 2014

    Report

    Report Number
    2432235-2014-00156
    Event Type
    Malfunction
    Date Received
    January 31, 2014
    Date of Event
    January 3, 2014
    Report Date
    January 6, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    NHS
    PMA / PMN Number
    K971418
    Removal / Correction Number
    2432235-08/20/14-006-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2432235-2014-00156 WAS FILED ON JANUARY 31, 2014. ADDITIONAL INFORMATION (08/12/2014): SIEMENS HEALTHCARE DIAGNOSTICS HAS IDENTIFIED AN ISSUE WITH PATIENT DEMOGRAPHIC INFORMATION SENT TO THE LIS FROM THE ADVIA CENTAUR/ADVIA CENTAUR XP IMMUNOASSAY SYSTEMS. SIEMENS HAS CONFIRMED THAT UNDER EXTREMELY RARE CIRCUMSTANCES PATIENT DEMOGRAPHIC DATA FROM THE PREVIOUS ORDER RECEIVED FROM THE LIS IS MERGED WITH THE NEXT ORDER. THIS ISSUE CAN OCCUR WHEN THE LIS DATA BUFFER ON THE ADVIA CENTAUR SYSTEM BECOMES FULL AND A PARTICULAR CHARACTER IS FOUND IN THE LAST FIVE LOCATIONS IN THE LIS DATA BUFFER. IN THIS CASE, THE INCORRECT PATIENT DEMOGRAPHIC INFORMATION WILL BE TRANSMITTED TO THE LIS AND WILL BE DISPLAYED ON THE ADVIA CENTAUR USER INTERFACE AND INSTRUMENT GENERATED PRINTED REPORTS. URGENT MEDICAL DEVICE CORRECTION (UMDC) 10819176 ENTITLED "ADVIA CENTAUR/ADVIA CENTAUR XP INCORRECT PATIENT DEMOGRAPHIC INFORMATION" WAS SENT TO CUSTOMERS IN THE UNITED STATES AND URGENT FIELD SAFETY NOTICE (UFSN) 10819175 ENTITLED "ADVIA CENTAUR/ADVIA CENTAUR XP INCORRECT PATIENT DEMOGRAPHIC INFORMATION" WAS SENT TO CUSTOMERS OUTSIDE THE UNITED STATES IN AUGUST 2014. THE UMDC AND UFSN DESCRIBE THE ISSUE AND PROVIDE ACTIONS FOR CUSTOMERS TO TAKE IF THEIR INSTRUMENT IS INTERFACED TO AN LIS SYSTEM THAT TRANSMITS PATIENT DEMOGRAPHICS WITH EACH ORDER. CORRECTED INFORMATION: THE PRODUCT CODE IN THE INITIAL MDR WAS LISTED AS JJE. THE CORRECT PRODUCT CODE IS MOI. THE 510(K) NUMBER IN THE INITIAL MDR WAS LISTED AS K041133. THE CORRECT 510(K) NUMBER IS K971418. THIS INFORMATION HAS BEEN CHANGED, RESPECTIVELY.

    Additional Manufacturer Narrative · 1

    A SIEMENS GLOBAL PRODUCT SUPPORT (GPS) SPECIALIST REVIEWED THE INSTRUMENT DATA AND DID NOT FIND AN INSTRUMENT MALFUNCTION. THE CUSTOMER STATED THAT THEIR LABORATORY INFORMATION SYSTEM (LIS), WHICH IS NOT A SIEMENS PRODUCT, HAD PRODUCED AN ERROR FOR AN UNKNOWN RECORD TYPE DURING THE RUN. THE CAUSE OF ONE PATIENT'S SID BEING INCORRECTLY MATCHED WITH THE NAME OF A DIFFERENT PATIENT IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE OPERATOR OF AN ADVIA CENTAUR XP INSTRUMENT RAN MULTIPLE PATIENT SAMPLES BEING TESTED FOR (B)(6). UPON REVIEW OF RESULTS AFTER THE RUN, THE OPERATOR DISCOVERED THAT ONE PATIENT'S SAMPLE IDENTIFICATION (SID) NUMBER WAS INCORRECTLY MATCHED WITH THE NAME OF A DIFFERENT PATIENT WHOSE SAMPLE HAD ALSO BEEN TESTED IN THE RUN. THE OTHER PATIENT'S SID HAD BEEN CORRECTLY MATCHED WITH THEIR NAME. THE ISSUE WAS IDENTIFIED PRIOR TO INCORRECT RESULTS BEING REPORTED TO THE PHYSICIAN(S) FOR ONE PATIENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO ONE PATIENT'S SID BEING INCORRECTLY MATCHED WITH THE NAME OF A DIFFERENT PATIENT .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67678 ADVIA CENTAUR XP IMMUNOASSAY ANALYZER NHS SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP

    Patients

    Seq Age Sex Outcome Treatment
    1