BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000

    MDR report key: 2170600 · Received July 21, 2011

    Report

    Report Number
    2247117-2011-00043
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 5, 2011
    Report Date
    June 27, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    DGC
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FSE (FIELD SERVICE ENGINEER) ANALYZED THE IMMULITE 2000 INSTRUMENT AND INSTRUMENT DATA. AFTER ANALYZING THE INSTRUMENT AND INSTRUMENT DATA THE FSE RAN A QC PRECISION TEST. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. THE CAUSE OF THE (B)(6) HBSAG RESULT IS UNKNOWN. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT (B)(6) IMMULITE 2000 HBSAG RESULT WAS GENERATED ON ONE PATIENT SAMPLE. THE SAMPLE WAS REPEATED IN DUPLICATE CONFIRMING (B)(6) RESULT, WHICH WAS REPORTED TO THE PHYSICIAN. THE PHYSICIAN REQUESTED THAT THE SAMPLE BE TESTED AT ANOTHER LAB FOR (B)(6) WHICH THEN GENERATED A (B)(6) RESULT. THERE WAS NO KNOWN REPORT OF TREATMENT GIVEN OR WITHHELD BASED ON THE DISCORDANT HBSAG RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 IMMUNO-ASSAY DGC SIEMENS HEALTHCARE DIAGNOSTICS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1