BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2000 OMMA (CA125)

    MDR report key: 1240876 · Received November 6, 2008

    Report

    Report Number
    2017183-2008-00043
    Event Type
    Other
    Date Received
    November 6, 2008
    Date of Event
    April 24, 2008
    Report Date
    July 7, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS LTD.
    Product Code
    LTK
    PMA / PMN Number
    K983391
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THERE ARE NO KNOWN CAUSE FOR THE DISCORDANT OM-MA RESULTS. IT'S SUSPECTED THAT FIBRIN IN THE SAMPLE MAY HAVE CONTRIBUTED TO THE DISCREPANT RESULTS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    LOWER THAN EXPECTED IMMULITE 2000 OM-MA (CA125) RESULTS WERE REPORTED TO THE PHYSICIAN ON TWO PATIENT SAMPLES WHICH DID NOT MATCH THE PATIENT'S HISTORICAL PICTURE. IT IS UNKNOWN IF THERE WAS ANY MEDICAL TREATMENT PRESCRIBED FOR THE PATIENT DUE TO THIS DISCORDANT RESULT. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT OM-MA (CA125) RESULT.

    Additional Manufacturer Narrative · 2

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THERE ARE NO KNOWN CAUSE FOR THE DISCORDANT OM-MA RESULTS. IT'S SUSPECTED THAT FIBRIN IN THE SAMPLE MAY HAVE CONTRIBUTED TO THE DISCREPANT RESULTS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 2

    LOWER THAN EXPECTED IMMULITE 2000 OM-MA (CA125) RESULTS WERE REPORTED TO THE PHYSICIAN ON TWO PATIENT SAMPLES WHICH DID NOT MATCH THE PATIENT'S HISTORICAL PICTURE. IT IS UNKNOWN IF THERE WAS ANY MEDICAL TREATMENT PRESCRIBED FOR THE PATIENT DUE TO THIS DISCORDANT RESULT. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT OM-MA (CA125) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 OMMA (CA125) OMMA (CA125) IMMUNOASSAY LTK SIEMENS HEALTHCARE DIAGNOSTICS LTD. NA 231

    Patients

    Seq Age Sex Outcome Treatment
    1
    2