BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ESTRADIOL III ASSAY

    MDR report key: 6282339 · Received January 27, 2017

    Report

    Report Number
    1823260-2017-00167
    Event Type
    Malfunction
    Date Received
    January 27, 2017
    Date of Event
    January 9, 2017
    Report Date
    April 10, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CHP
    PMA / PMN Number
    K965109
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    SAMPLE FROM THE PATIENT WAS SUBMITTED FOR INVESTIGATION AND THE CUSTOMER'S LOWER RESULTS WERE REPRODUCED. TESTING BY LC-MS/MS CONFIRMED A HIGH ESTRADIOL CONCENTRATION OF APPROXIMATELY 35500 PMOL/L. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. A POSSIBLE EXPLANATION OF THE DIFFERENCE IN THE RESULTS COULD BE AN INTERFERING FACTOR PRESENT IN THE SAMPLE.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE ELECSYS ESTRADIOL III ASSAY RESULTS FROM THE COBAS 6000 E 601 MODULE WHEN COMPARED TO THE RESULTS FROM A SIEMENS CENTAUR ANALYZER. THE RESULT FROM THE SIEMENS CENTAUR ANALYZER WAS 38000 PMOL/L. THE SAME SAMPLE WAS SENT TO THIS LABORATORY AND WAS ANALYZED ON THE COBAS 6000 E 601 MODULE AND THE RESULT WAS 1800 PMOL/L. THE SAMPLE WAS REPEATED AND THE RESULT WAS 1862 PMOL/L. THE CUSTOMER THEN PERFORMED DILUTIONS OF THE SAMPLE. 1:2: 5436 PMOL/L. 1:5: 18122 AND 18330 PMOL/L. 1:10: 31734 AND 31250 PMOL/L. 1:20: 35960 PMOL/L. 1:100: 35790 PMOL/L. THE SAMPLE WAS REPEATED ON THE SIEMENS CENTAUR ANALYZER AND THE RESULT WAS AROUND 37000 PMOL/L TWICE. INFORMATION CONCERNING IF ANY ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY WAS REQUESTED BUT IT WAS UNKNOWN. THE PATIENT WAS NOT ADVERSELY AFFECTED. NO OTHER PATIENT SAMPLE RESULTS WERE QUESTIONED. THE QC RESULTS WERE ACCEPTABLE. THE SERIAL NUMBER OF THE E 601 MODULE WAS REQUESTED BUT NOT PROVIDED. THE CUSTOMER SUSPECTED THERE WAS HAMA INTERFERENCE WITH THE ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66512 ELECSYS ESTRADIOL III ASSAY RADIOIMMUNOASSY, ESTRADIOL CHP ROCHE DIAGNOSTICS NA 145434

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR