BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000

    MDR report key: 3433653 · Received October 28, 2013

    Report

    Report Number
    2247117-2013-00109
    Event Type
    Malfunction
    Date Received
    October 28, 2013
    Date of Event
    October 3, 2013
    Report Date
    October 3, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LJK
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS APPLICATION SPECIALIST WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT DATA, THE APPLICATION SPECIALIST DID NOT FIND A MALFUNCTION WITH THE IMMULITE 2000 INSTRUMENT. IT WAS DISCOVERED THAT THE LIS WAS NOT CONFIGURED TO INTERPRET THE RESULT OF >10. THE CUSTOMER THEN RECONFIGURED THEIR LIS HOST TO INTERPRET RESULTS THAT WERE TRANSMITTED FROM THE IMMULITE 2000 INSTRUMENT. THE CAUSE OF THE POSITIVE TOXOPLASMA IGM RESULT BEING MISINTERPRETED BY THE LIS AS A NEGATIVE RESULT WAS A CONFIGURATION ISSUE. THE IMMULITE 2000 INSTRUMENT PERFORMED ACCORDING TO SPECIFICATIONS. THIS DEVICE IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    ONE PATIENT SAMPLE TESTED FOR TOXOPLASMA IGM RESULTED POSITIVE ON AN IMMULITE 2000 INSTRUMENT. THE RESULT WAS REPORTED TO THE LABORATORY INFORMATION SYSTEM (LIS), WHICH MISINTERPRETED THE RESULT AS NEGATIVE. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S) BECAUSE THE OPERATOR DISCOVERED THE DISCREPANCY BEFORE THE RESULT WAS REPORTED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE POSITIVE TOXOPLASMA IGM RESULT BEING INTERPRETED AS NEGATIVE BY THE LIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552948 IMMULITE 2000 IMMULITE 2000 LJK SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000

    Patients

    Seq Age Sex Outcome Treatment
    1