BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP

    MDR report key: 2223647 · Received August 25, 2011

    Report

    Report Number
    2432235-2011-00115
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 27, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    JJE
    PMA / PMN Number
    K902336
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    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 PATIENT INFORMATION NOT MATCHING THE SAMPLE IDENTIFICATION WAS THE RE-USE OF THE SAMPLE IDENTIFICATION NUMBERS ON THE SYSTEM BY THE USER WITHOUT DELETING THE PREVIOUS SAMPLE INFORMATION AS REQUIRED BY THE PRODUCT LABELING INSTRUCTIONS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    RESULT REPORTS WHERE THE PATIENT INFORMATION DID NOT MATCH THE SAMPLE IDENTIFICATION (SID) WERE OBTAINED ON THE ADVIA CENTAUR CP INSTRUMENT. NO INCORRECT REPORTS WERE RELEASED AS THE LABORATORY IS MANUALLY CHECKING ALL PATIENT INFORMATION ON RESULT REPORTS. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES OR PATIENT INTERVENTION DUE TO THE PATIENT INFORMATION NOT MATCHING THE SAMPLE IDENTIFICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1