BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 4810641 · Received June 2, 2015

    Report

    Report Number
    1823260-2015-03573
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Date of Event
    May 11, 2015
    Report Date
    June 2, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    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).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED FOR THYROTROPIN (TSH) AND FREE THYROXINE (FT4). THE SAMPLE INITIALLY RESULTED AS 0.02 UIU/ML FOR TSH AND 0.0 NG/DL FOR FT4. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND WERE QUESTIONED BY PHYSICIANS. THE SAMPLE WAS REPEATED ON (B)(6) 2015 AND RESULTED AS 0.36 UIU/ML FOR TSH AND 1.6 NG/DL FOR FT4. THE REPEAT RESULTS WERE ALSO REPORTED OUTSIDE OF THE LABORATORY. A NEW SAMPLE WAS ALSO COLLECTED FROM THE PATIENT AND TESTED ON (B)(6) 2015. THE RESULTS FROM THE NEW SAMPLE WERE COMPARABLE TO PREVIOUS MEASUREMENTS AND THE REPEATED RUN OF THE ORIGINAL SAMPLE. IT WAS ASKED, BUT IT IS NOT KNOWN IF THE PATIENT WAS ADVERSELY AFFECTED. NO ADVERSE EVENTS WERE ALLEGED. THE TSH REAGENT LOT NUMBER WAS 183222, WITH AN EXPIRATION DATE OF 09/29/2015. THE FT4 REAGENT LOT NUMBER WAS 181732, WITH AN EXPIRATION DATE OF 01/30/2016. IT WAS NOTED THAT THERE WERE SEVERAL ERROR MESSAGES INDICATING THAT THERE WERE SAMPLE PIPETTING ISSUES, BUT IT IS ASSUMED THAT THE MESSAGES WERE NOT GENERATED FOR THE AFFECTED PATIENT SAMPLE. THE ANALYZER WAS CHECKED AND NO ROOT CAUSE COULD BE IDENTIFIED. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. ADDITIONAL INFORMATION REQUIRED FOR THE INVESTIGATION WAS REQUESTED, BUT NOT PROVIDED. A REAGENT ISSUE COULD NOT BE IDENTIFIED. THE MOST LIKELY CAUSE IS A SAMPLE PIPETTING ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356766 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1