BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 2994250 · Received March 8, 2013

    Report

    Report Number
    1823260-2013-01384
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 18, 2013
    Report Date
    March 8, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    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).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE FREE THYROXINE (FT4) AND THYROTROPIN (TSH) RESULTS FOR TWO PATIENTS ON THEIR ELECSYS 2010 ANALYZER. THE INITIAL RESULTS WERE TESTED IN THE PRIMARY TUBES. THE REPEAT RESULTS WERE FROM SAMPLE CUPS. THE CUSTOMER STATED THE SAMPLE WAS CLEAR WITHOUT ANY CLOTS OR FIBRIN AND THE SAMPLE LEVEL WAS OVER HALF THE TUBE. THE FIRST PATIENT'S INITIAL FT4 RESULT WAS <0.023 NG/DL ACCOMPANIED BY A DATA FLAG, BUT IT WAS UNCLEAR WHAT THE DATA FLAG WAS. THE REPEAT RESULT WAS 1.33 NG/DL. THE FIRST PATIENT'S INITIAL TSH RESULT WAS 0.019 UIU/ML ACCOMPANIED BY A DATA FLAG, BUT IT WAS UNCLEAR WHAT THE DATA FLAG WAS. THE REPEAT RESULT WAS 0.410 UIU/ML. THE SECOND PATIENT'S INITIAL FT4 RESULT WAS <0.023 NG/DL ACCOMPANIED BY A DATA FLAG, BUT IT WAS UNCLEAR WHAT THE DATA FLAG WAS. THE REPEAT RESULT WAS 0.844 NG/DL ACCOMPANIED BY A DATA FLAG, BUT IT WAS UNCLEAR WHAT THE DATA FLAG WAS. THE SECOND PATIENT'S INITIAL TSH RESULT WAS 0.018 UIU/ML ACCOMPANIED BY A DATA FLAG, BUT IT WAS UNCLEAR WHAT THE DATA FLAG WAS. THE REPEAT RESULT WAS 0.075 UIU/ML. THE REPEAT RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THERE WERE NO ADVERSE EVENTS. THE FT4 AND TSH REAGENT LOT NUMBERS AND EXPIRATION DATES WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE ADJUSTED THE SAMPLE PROBE AND ADJUSTED THE ROLLER TUBE CAPTURE ON THE B-LINE. THE PROBLEM DID NOT RE-OCCUR. THE FIELD SERVICE REPRESENTATIVE MONITORED THE SITUATION FOR ONE WEEK. THE CUSTOMER WAS SENT THE RECOMMENDED RACK ADAPTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99121 ELECSYS 2010 RACK IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1