BEUDAMED
    FDA Adverse Event Summary report: N

    ADVIA CENTAUR

    MDR report key: 1980855 · Received February 7, 2011

    Report

    Report Number
    2432235-2011-00017
    Date Received
    February 7, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 20, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K971418
    Removal / Correction Number
    2432235-08/15/14-005-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER(FSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER ANALYZING THE INSTRUMENT DATA, THE FSE DETERMINED THAT THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. THE CAUSE OF THE SAMPLE TRANSPOSITION IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2432235-2011-00017 WAS FILED ON FEBRUARY 07, 2011. SIEMENS HEALTHCARE DIAGNOSTICS HAS INVESTIGATED THE INSTANCES OF MISREAD BARCODED TUBE SAMPLE IDS (SID) ON ADVIA CENTAUR AND ADVIA CENTAUR XP IMMUNOASSAY SYSTEMS. SIEMENS HEALTHCARE DIAGNOSTICS HAS CONFIRMED THAT MANUALLY LOADED SAMPLE RACKS THAT ARE IMPROPERLY LOADED OR PUSHED TOO FAR ON THE SAMPLE ENTRY QUEUE DURING NORMAL OPERATION OF THE ADVIA CENTAUR AND ADVIA CENTAUR XP IMMUNOASSAY SYSTEMS MAY CAUSE MISREADS OF SIDS IF THE SAMPLE RACK LOADING INSTRUCTIONS ARE NOT FOLLOWED EXACTLY AS DESCRIBED IN THE ADVIA CENTAUR OR ADVIA CENTAUR XP OPERATOR'S GUIDE. URGENT MEDICAL DEVICE CORRECTION (UMDC) (B)(4) ENTITLED "ADVIA CENTAUR/ADVIA CENTAUR XP IMPROPER LOADING OF SAMPLE RACKS" WAS SENT TO CUSTOMERS IN THE UNITED STATES IN AUGUST 2014. URGENT FIELD SAFETY NOTICE (UFSN) (B)(4) ENTITLED "ADVIA CENTAUR/ADVIA CENTAUR XP IMPROPER LOADING OF SAMPLE RACKS" WAS SENT TO CUSTOMERS OUTSIDE OF THE UNITED STATES IN AUGUST 2014. THE UMDC/UFSN PROVIDES THE CUSTOMER WITH ACTIONS TO TAKE TO PREVENT THIS ISSUE FROM OCCURRING.

    Description of Event or Problem · 1

    A MIS-READ BARCODE CAUSED TRANSPOSITION OF PATIENT SAMPLES TO THE WRONG SAMPLE RACK POSITIONS ON AN ADVIA CENTAUR INSTRUMENT. NO INCORRECT RESULTS WERE REPORTED. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PATIENT INTERVENTION DUE TO THE SAMPLE TRANSPOSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR IMMUNOASSAY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS ADVIA CENTAUR N/A

    Patients

    Seq Age Sex Outcome Treatment
    1