BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMULITE 2000

    MDR report key: 3222778 · Received July 12, 2013

    Report

    Report Number
    2247117-2013-00070
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 17, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJQ
    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 GLOBAL PRODUCT SUPPORT (GPS) SPECIALIST EVALUATED THE INSTRUMENT DATA. AFTER EVALUATING THE INSTRUMENT DATA, THE GPS SPECIALIST DID NOT FIND ANY RELATED ERRORS IN THE INSTRUMENT EVENT LOG. THE CAUSE OF THE DISCORDANT ESTRADIOL VALUE IS UNKNOWN. THIS INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT LOW ESTRADIOL RESULT WAS OBTAINED ON AN IMMULITE 2000 INSTRUMENT. THE SAMPLE WAS RUN NEAT AND AT A 1:3 DILUTION ON (B)(6) 2013 AND NEAT SAMPLE IN DUPLICATE AND AT A 1:3 DILUTION ON (B)(6) 2013. THE DISCORDANT RESULT WAS OBTAINED ON THE FIRST NEAT SAMPLE RUN ON (B)(6) 2013. THE THREE LEVELS OF QC WERE IN RANGE THE DAY THE DISCORDANT SAMPLE RESULT WAS OBTAINED. THE CUSTOMER QUESTIONED THE INITIAL NEAT RESULT ON (B)(6) 2013 AS IT DID NOT MATCH THE RESULT OF THE SAMPLE RUN ON THE PREVIOUS DAY. THE RESULT OF THE 1:3 DILUTION ON (B)(6) 2013 WAS REPORTED TO THE PHYSICIAN. THERE WERE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ESTRADIOL RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324127 IMMULITE 2000 IMMULITE 2000 JJQ SIEMENS HEALTHCARE DIAGNOSTICS IMMULITE 2000

    Patients

    Seq Age Sex Outcome Treatment
    1