BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTRADIOL II

    MDR report key: 2133413 · Received June 20, 2011

    Report

    Report Number
    1823260-2011-03333
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    April 14, 2011
    Report Date
    September 15, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CHP
    PMA / PMN Number
    K965109
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE DOCTORS DID NOT START THERAPY BEFORE CONFIRMATION OF THE E2 RESULTS WITH FSH AND LH RESULTS (AND SOME ADDITIONAL RESULTS WHICH WERE NOT PROVIDED).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE. POSSIBLE CAUSES ARE SAMPLE HANDLING RELATED SUCH AS GLOVE WEARING NOT ADHERED TO, OR SAMPLE PREPARATION RELATED. A DEVICE RELATED ISSUE WAS NOT SUSPECTED AS CALIBRATION DATA PERFORMANCE DATA WAS ACCEPTABLE. NO ADVERSE EVENTS OCCURRED.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE ESTRADIOL (E2) RESULTS FOR 50 PATIENTS. TESTING WAS PERFORMED ON AN ELECSYS 2010 ANALYZER (SERIAL UNKNOWN) AND A COBAS E411 ANALYZER (SERIAL NUMBER (B)(4)). SAMPLES FROM FEMALE CHILDREN AND ADOLESCENTS WERE TESTED FOR E2 FOR HORMONE TESTING FOLLOW-UP. THE EXACT AGE OF THE PATIENTS IS UNKNOWN. EXPECTED E2 VALUES FOR THIS POPULATION ARE "IN GENERAL VERY LOW". INITIALLY THE SAMPLES WERE TESTED ON THE ELECSYS 2010 ANALYZER AND THE VALUES WERE HIGHER THAN EXPECTED. THEREFORE THE SAME SAMPLES WERE REPEATED ON THE COBAS E411 ANALYZER AND RECOVERED LOWER RESULTS WHICH WERE MORE CONSISTENT WITH THE CLINICAL PICTURES OF THE PATIENTS. THE CUSTOMER PROVIDED E2 RESULTS FOR 11 PATIENT SAMPLES. RESULTS FOR THREE OF THE SAMPLES WERE ERRONEOUS. ALL INITIAL TESTING WAS PERFORMED ON THE ELECSYS 2010 ANALYZER AND ALL REPEAT TESTING WAS PERFORMED ON THE COBAS E411 ANALYZER. SAMPLE 1, INITIAL RESULT WAS 112 PMOL/L. THE REPEAT RESULT WAS 43.60 PMOL/L. SAMPLE 2, INITIAL RESULT WAS 142 PMOL/L. THE REPEAT RESULT WAS 44.39 PMOL/L. SAMPLE 3, INITIAL RESULT WAS 115 PMOL/L. THE REPEAT RESULT WAS 63 PMOL/L. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENTS WERE NOT HARMED BY ANY ACTIONS TAKEN. NO PATIENTS WERE ADVERSELY AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESTRADIOL II RADIOIMMUNOASSAY, ESTRADIOL CHP ROCHE DIAGNOSTICS NA 159317

    Patients

    Seq Age Sex Outcome Treatment
    1