BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2000 OMMA (CA125)

    MDR report key: 1406862 · Received March 10, 2009

    Report

    Report Number
    2017183-2008-00073
    Event Type
    Other
    Date Received
    March 10, 2009
    Date of Event
    August 1, 2008
    Report Date
    August 19, 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 Location
    VA, US
    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. 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 ((B) (4)) 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 ((B) (4)) 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 232

    Patients

    Seq Age Sex Outcome Treatment
    1