BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000

    MDR report key: 3761845 · Received April 21, 2014

    Report

    Report Number
    2247117-2014-00022
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 27, 2014
    Manufacturer
    SIEMENS HEALTCHCARE DIAGNOSTICS INC
    Product Code
    JJQ
    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 CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE CSE REPLACED A SAMPLE PROBE AND DILUTION WELL. THE CSE ALIGNED THE SAMPLE PROBE TO THE DILUTION WELL. THE CAUSE OF THE DISCORDANT, FALSELY LOW ESTRADIOL RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY LOW ESTRADIOL RESULTS WERE OBTAINED ON TWO DILUTED PATIENT SAMPLES ON AN IMMULITE 2000 INSTRUMENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED WITH THE SAME DILUTION FACTOR ON THE SAME INSTRUMENT, RESULTING HIGHER. THE CUSTOMER DID NOT PROVIDE A VALUE FOR THE SECOND PATIENT BUT STATED THE RESULT WAS CLOSER TO 2000. THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW ESTRADIOL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240995 IMMULITE 2000 IMMULITE 2000 JJQ SIEMENS HEALTCHCARE DIAGNOSTICS INC IMMULITE 2000

    Patients

    Seq Age Sex Outcome Treatment
    1