BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 3555062 · Received January 6, 2014

    Report

    Report Number
    1823260-2014-00118
    Event Type
    Malfunction
    Date Received
    January 6, 2014
    Date of Event
    December 26, 2013
    Report Date
    February 13, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE. AN ISSUE WITH PREANALYTICS WAS SUSPECTED AS NORMAL RESULTS WERE GENERATED AFTER THE SAMPLE WAS RECENTRIFUGED. REVIEW OF THE PROVIDED CALIBRATION, QC AND ANALYZER DATA DID NOT INDICATE ANY ISSUES.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE THYROTROPIN (TSH) AND FREE THYROXINE (FT4) RESULTS FOR ONE PATIENT SAMPLE. THE INITIAL TSH RESULT WAS 0.033 IU/ML AND THE INITIAL FT4 RESULT WAS 0.023 NG/DL WITH A DATA FLAG. THE SAMPLE WAS RECENTRIFUGED AND THE REPEAT TSH RESULT WAS 0.914 IU/ML AND REPEAT FT4 RESULT WAS 1.34 NG/DL. THE SAMPLE WAS TESTED A THIRD TIME WITH A TSH RESULT OF 0.929 UIU/ML AND AN FT4 RESULT OF 1.37 NG/DL. THE REPEAT RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE TSH REAGENT LOT NUMBER WAS 173808. THE FT4 REAGENT LOT NUMBER WAS 172999. THE EXPIRATION DATES WERE REQUESTED, BUT WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6208 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 046 YR