BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2500 OMMA (CA125)

    MDR report key: 1062855 · Received June 18, 2008

    Report

    Report Number
    2017183-2008-00013
    Event Type
    Other
    Date Received
    June 18, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 14, 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 INDICATED THERE WERE MULTIPLE CLOT DETECTION ERRORS, WHICH INDICATES SAMPLE HANDLING ISSUES. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A LOWER THAN EXPECTED IMMULITE 2500 OM-MA (CA125) ASSAY RESULT WAS REPORTED TO THE PHYSICIAN (19.5 NG/ML). THIS RESULT WAS QUESTIONED BY THE PHYSICIAN AND UPON REPEAT THE PATIENT RESULTS WERE 4546.77 NG/ML AND 18175.01 NG/ML. 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 2500 OMMA (CA125) OMMA (CA125) IMMUNOASSAY LTK SIEMENS HEALTHCARE DIAGNOSTICS LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1