BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP

    MDR report key: 3930459 · Received July 11, 2014

    Report

    Report Number
    2432235-2014-00417
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 17, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MOI
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) WAS CONTACTED BY THE CUSTOMER. AFTER ANALYZING THE DATA, THE HSC DETERMINED THAT THE CAUSE OF THE (B)(6) QUALITY CONTROL BRACKET SETTING OF "1" WAS DUE TO THE INCORRECT CONTROL BRACKET SETTING WITHIN THE SOFTWARE. THE PROBLEM WAS CORRECTED BY A SIEMENS CUSTOMER SERVICE ENGINEER, WHO WAS DISPATCHED TO THE CUSTOMER SITE AND CHANGED THE QUALITY CONTROL BRACKET SETTING IN THE SOFTWARE FROM "1" TO "4". THE CSE SAVED THE CHANGE IN THE SOFTWARE AND SUCCESSFULLY RAN (B)(6) QC. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER A SOFTWARE UPDATE WAS PERFORMED ON AN ADVIA CENTAUR CP INSTRUMENT, THE (B)(6) QUALITY CONTROL RESULTS WERE CONFIGURED TO RUN WITH CONTROL BRACKETING SET TO "1" INSTEAD OF "4", ENABLING THE INSTRUMENT TO RUN PATIENT SAMPLES AFTER ONE QC PASSED INSTEAD OF FOUR. THE CUSTOMER OBSERVED THE ISSUE AND MANUALLY RAN (B)(6) QUALITY CONTROL LEVELS 2, 3 AND 4 ON (B)(6) SAMPLES. THERE WERE NO DISCORDANT (B)(6) RESULTS GENERATED OR RELEASED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE (B)(6) QUALITY CONTROL RESULTS CONFIGURED TO RUN WITH CONTROL BRACKETING SET TO "1".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408116 ADVIA CENTAUR CP IMMUNOASSAY ANALYZER MOI SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR CP

    Patients

    Seq Age Sex Outcome Treatment
    1