BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000

    MDR report key: 3725038 · Received April 3, 2014

    Report

    Report Number
    2432235-2014-00255
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 14, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CIZ
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2432235-2014-00255 WAS FILED ON APRIL 3, 2014. THE INITIAL MDR WAS FILED AGAINST THE IMMULITE 2000 (B)(6). BASED ON FURTHER INVESTIGATIONS AND SERVICE BY SIEMENS FIELD SERVICE ENGINEER (FSE), IT WAS DETERMINED THAT THE IMMULITE 2000 (B)(6) WAS PERFORMING AS PER SPECIFICATIONS. ADDITIONAL INFORMATION (3/14/2014): A FSE WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT, THE FSE REPLACED AND ADJUSTED PROBES, THE DUAL RESOLUTION DILUTOR (DRD) SEALS, AND SPRINGS. IN ADDITION A ROUTINE PREVENTATIVE MAINTENANCE AND A SYSTEM DECONTAMINATION WAS COMPLETED. (B)(6) ADJUSTORS AND QUALITY CONTROL SAMPLES WERE RUN ON THE INSTRUMENT AND RECOVERED WITHIN SPECIFICATIONS. THE CAUSE OF THE (B)(6) RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE (B)(6) RESULTS FOR (B)(6) ON THE IMMULITE 2000 IS UNKNOWN. SIEMENS DIAGNOSTICS IS INVESTIGATING THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED (B)(6) RESULTS ON TWO PATIENT SAMPLES FOR THE (B)(6) WHEN USING REAGENT LOT 696 ON AN IMMULITE 2000 INSTRUMENT. THE CUSTOMER ALSO OBSERVED THAT QUALITY CONTROL SAMPLES WERE RUNNING LOW OR OUT OF SPECIFICATION WHEN USING REAGENT LOT 696. THE PATIENT SAMPLES WERE FIRST RUN USING REAGENT LOT 696 AND THEN REPEATED USING REAGENT LOT 695. THE TWO PATIENT SAMPLES WERE (B)(6) WHEN TESTED USING REAGENT LOT 695. THE (B)(6) RESULTS WERE REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN IF THE (B)(6) RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202932 IMMULITE 2000 IMMULITE 2000 CIZ SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000 696

    Patients

    Seq Age Sex Outcome Treatment
    1