BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2000

    MDR report key: 1909285 · Received November 19, 2010

    Report

    Report Number
    2247117-2010-00051
    Event Type
    Other
    Date Received
    November 19, 2010
    Date of Event
    October 12, 2010
    Report Date
    November 8, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    DGC
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAS REFUSED A SERVICE VISIT AS THEY FEEL THAT THIS IS A SAMPLE SPECIFIC ISSUE. A SIEMENS HEALTHCARE TECHNICAL SERVICE ENGINEER (TSE) EVALUATED THE INSTRUMENT DATA (FROM (B)(4) 2010 ONLY, INSTRUMENT DATA FILES FROM (B)(4) 2010 AND (B)(4) 2010 NOT AVAILABLE). ANALYSIS OF THE INSTRUMENT DATA INDICATE THAT THERE WERE NO ISSUES FOUND IN THE FILE. IT IS THOUGHT THAT THE ROOT CAUSE IS DUE TO USER ERROR BECAUSE THE TECHNICIANS IGNORED THE DELTA CHECK, WHICH SHOULD HAVE ALERTED THEM TO REPEAT THE SAMPLE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    ONE (1) DISCORDANT HIGH IMMULITE 2000 OV RESULT WAS OBTAINED ON ONE PATIENT SAMPLE. THE LABORATORY HAD BEEN MONITORING A PATIENT (WITH A PRIOR HISTORY OF OVARIAN CANCER) ON A MONTHLY BASIS. THIS PATIENT HAD RECEIVED CHEMOTHERAPY WHICH MAKES CLOTTING UNPREDICTABLE. AFTER RUNNING THE PATIENT SAMPLE, THE TECHNICIANS IGNORED THE DELTA CHECK FLAG, WHICH SHOULD HAVE ALERTED THEM TO REPEAT THE SAMPLE. PATIENT RECEIVED A BIOPSY, 2 RADIOGRAPHS AND WAS SET UP FOR CHEMOTHERAPY (WHICH WAS NOT INITIATED). REPEAT RESULT THE FOLLOWING MONTH DETERMINED THAT THE PREVIOUS MONTH'S RESULT WAS DISCORDANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 IMMUNO-ASSAY DGC SIEMENS HEALTHCARE DIAGNOSTICS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1