BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2016-00487

    MDR report key: 5605458 · Received April 25, 2016

    Report

    Report Number
    1823260-2016-00487
    Event Type
    Malfunction
    Date Received
    April 25, 2016
    Date of Event
    April 8, 2016
    Report Date
    July 18, 2016
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    INVESTIGATIONS HAVE DETERMINED THE ROOT CAUSE TO BE CONTAMINATION OF THE ENVIRONMENT WITH ESTRADIOL. THE ANALYZER WAS FOUND TO BE WORKING WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF DUST COLLECTED FROM THE CUSTOMER'S ANALYZER REVEALED THAT IT CONTAINS HIGH LEVELS OF ESTRADIOL. AFTER CLEANING THE ANALYZER, SOME DECREASE IN ESTRADIOL CONCENTRATION OF COLLECTED DUST WAS CONFIRMED. ADDITIONAL CLEANING PROCEDURES ARE ONGOING TO ADDRESS THE ESTRADIOL CONTAMINATION.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR ESTRADIOL ON THE E602 ANALYZER. IT WAS ASKED, BUT IT IS UNKNOWN IF AN ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. IT WAS STATED THAT THE CUSTOMER MEASURES PATIENT SAMPLES IN DUPLICATE. THE SAMPLE INITIALLY RESULTED AS 47.50 PG/ML. THE SAMPLE WAS REPEATED, RESULTING AS 98.50 PG/ML. THE SAMPLE WAS REPEATED ON A SECOND E602 ANALYZER, RESULTING AS 48.58 PG/ML. THE SAMPLE WAS REPEATED AGAIN ON THE ORIGINAL E602 ANALYZER, RESULTING AS 50.52 PG/ML. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE ESTRADIOL REAGENT LOT NUMBER WAS 120670-012, WITH AN EXPIRATION DATE OF 04/08/2016.

    Patients

    Seq Age Sex Outcome Treatment
    1