BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000

    MDR report key: 3229921 · Received July 16, 2013

    Report

    Report Number
    2247117-2013-00071
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LGD
    PMA / PMN Number
    K970227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE FSE REPLACED MULTIPLE PARTS INCLUDING THE SAMPLE DUAL RESOLUTION DILUTER (DRD), SAMPLE VALVE, SAMPLE PROBE, SAMPLE LEVEL SENSE PRINTED CIRCUIT BOARD (PCB), REAGENT PROBE, REAGENT LEVEL SENSE PCB, SLAVE 0/1 PCB AND DUAL PIPETTE CABLES. QUALITY CONTROLS WERE THEN RUN AND WERE IN RANGE. THE CAUSE OF THE DISCORDANT, FALSELY LOW E2 RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE COMMON DEVICE NAME WAS INCORRECTLY STATED AS: CLINICAL CHEMISTRY, PRODUCT CODE: LXG. THE CORRECT COMMON DEVICE NAME IS: CLINICAL CHEMISTRY, PRODUCT CODE: DGC. THE CATALOG NUMBER WAS INCORRECTLY STATED AS: BLANK FIELD. THE CORRECT CATALOG NUMBER IS: 30002.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY LOW ESTRADIOL (E2) RESULT WAS OBTAINED FOR ONE PATIENT SAMPLE ON AN IMMULITE 2000 INSTRUMENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS RERUN ON THE SAME INSTRUMENT AND RESULTED HIGHER AND THE RERUN RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW E2 RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328311 IMMULITE 2000 CLINICAL CHEMISTRY LGD SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000

    Patients

    Seq Age Sex Outcome Treatment
    1