BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP CA 125II ASSAY

    MDR report key: 2441317 · Received February 7, 2012

    Report

    Report Number
    1219913-2012-00043
    Event Type
    Malfunction
    Date Received
    February 7, 2012
    Date of Event
    January 9, 2012
    Report Date
    January 13, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LTK
    PMA / PMN Number
    K020828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. BASED ON THE INFORMATION PROVIDED AND INSTRUMENT EVALUATION, THE FSE REPLACED THE SAMPLE PROBE WITH TUBING ASSEMBLY, ADJUSTED THE AIR PRESSURE AND CLEANED THE LUMONOMETER. THE FSE VERIFIED SYSTEM IS OPERATIONAL. NO CONCLUSION CAN BE DRAWN. PREANALYTICAL FACTORS CAN NOT BE RULED OUT. PREANALYTIC VARIABLES CAN AFFECT THE QUALITY OF THE SAMPLE, AND DEVIATION FROM RECOMMENDED BEST PRACTICES CAN LEAD TO ERRONEOUS RESULTS. IT IS POSSIBLE THAT A PREANALYTIC VARIABLE SUCH AS MICROFIBRIN OR INCOMPLETE SPECIMEN CLOTTING COULD HAVE CAUSED AN INCORRECT VOLUME OF SAMPLE TO BE ASPIRATED CAUSING THE LOWER RESULTS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A LOW ADVIA CENTAUR CP CA 125II RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS DISCORDANT WITH THE RESULT OF A SECOND DRAW. THE PHYSICIAN QUESTIONED THE RESULTS. REPEAT TESTING WAS PERFORMED FOR BOTH SAMPLES AND THE RESULTS WERE SIMILAR. A CORRECTED REPORT WAS GENERATED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA 125II RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR CP CA 125II ASSAY CA 125II IMMUNOASSAY LTK SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 150

    Patients

    Seq Age Sex Outcome Treatment
    1