BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2017-00422

    MDR report key: 6358036 · Received February 24, 2017

    Report

    Report Number
    1823260-2017-00422
    Event Type
    Malfunction
    Date Received
    February 24, 2017
    Date of Event
    February 7, 2017
    Report Date
    February 24, 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 TESTED FOR ELECSYS FT4 II ASSAY(FT4 II) ON A COBAS 8000 E 602 MODULE. IT IS NOT KNOWN IF THE ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER PROVIDED THE PATIENT SAMPLE FOR INVESTIGATION. BASED ON THE DATA GENERATED DURING THE INVESTIGATION, ERRONEOUS RESULTS WERE IDENTIFIED BETWEEN THE CUSTOMER¿S E602 MODULE, A COBAS 6000 E 601 MODULE USED AT THE INVESTIGATION SITE AND A COBAS E 411 IMMUNOASSAY ANALYZER USED AT THE INVESTIGATION SITE. REFER TO THE ATTACHED DATA FOR PATIENT RESULTS. A RESULT OF 1.18 NG/DL WAS REPORTED OUTSIDE OF THE LABORATORY. NO ADVERSE EVENT OCCURRED. THE CUSTOMER¿S FT4 II REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. THE CUSTOMER DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION. BASED ON THE INFORMATION PROVIDED, A GENERAL REAGENT ISSUE WAS NOT DETECTED. EXCEPT FOR THE FT4 II RESULT OF >7.77 NG/D FROM THE CUSTOMER¿S E602 MODULE, ALL OTHER RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE. POSSIBLE ROOT CAUSES FOR THIS EVENT MAY BE IMPROPER HANDLING OF THE REAGENT OR SYSTEM REAGENTS, OR CONTAMINATION OF THE ENVIRONMENT WITH THE ANALYTE.

    Patients

    Seq Age Sex Outcome Treatment
    1