BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2017-02262

    MDR report key: 6939763 · Received October 11, 2017

    Report

    Report Number
    1823260-2017-02262
    Event Type
    Malfunction
    Date Received
    October 11, 2017
    Date of Event
    September 12, 2017
    Report Date
    October 11, 2017
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF AN ERRONEOUS HIGH RESULT FOR 1 PATIENT SAMPLE TESTED 3 TIMES FOR ELECSYS FT4 II ASSAY (FT4 II) ON A COBAS 8000 E 602 MODULE. THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER SUBMITTED THE SAMPLE FOR INVESTIGATION AND THE RESULTS FROM AN E602 MODULE USED AT THE INVESTIGATION SITE AND A COBAS E 411 IMMUNOASSAY ANALYZER USED AT THE INVESTIGATION SITE WERE ERRONEOUS COMPARED TO THE 1 HIGH RESULT THE CUSTOMER RECEIVED. THE FT4 II RESULTS GENERATED DURING THE INVESTIGATION COMPARED WELL TO THE OTHER TWO FT4 II RESULTS FROM THE CUSTOMER¿S E602 MODULE. REFER TO ATTACHED DATA FOR THE PATIENT RESULTS. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE FT4 II REAGENT LOT NUMBER AND EXPIRATION DATE USED AT THE CUSTOMER SITE WERE NOT PROVIDED. THE E602 MODULE SERIAL NUMBER USED AT THE INVESTIGATION SITE WAS (B)(4). THE E411 ANALYZER SERIAL NUMBER WAS 0600-12. THE FT4 II REAGENT LOT NUMBER USED AT THE INVESTIGATION SITE WAS 215455 WITH AN EXPIRATION DATE OF 31-MAR-2018. A SPECIFIC ROOT CAUSE WAS NOT IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED FOR INVESTIGATION BUT WAS NOT PROVIDED. EXCEPT FOR THE HIGH RESULT OF 2.36 NG/DL GENERATED AT THE CUSTOMER SITE, ALL OTHER VALUES GENERATED AT THE CUSTOMER SITE AND THE INVESTIGATION SITE WERE WITHIN THE NORMAL REFERENCE RANGES OF THE ASSAY. BASED ON THE INFORMATION AVAILABLE, A GENERAL REAGENT ISSUE IS NOT LIKELY. POSSIBLE ROOT CAUSES FOR THE HIGH RESULT MAY BE RELATED TO A SAMPLE SPECIFIC ISSUE SUCH AS PRE-ANALYTIC PREPARATION OR TO REAGENT SPECIFIC ISSUE SUCH AS THE PRESENCE OF FOAM OR BUBBLES ON THE REAGENT SURFACE.

    Patients

    Seq Age Sex Outcome Treatment
    1