BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 2854518 · Received December 3, 2012

    Report

    Report Number
    1823260-2012-06065
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 15, 2012
    Report Date
    December 3, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED ANALYZER ALARMS AND NOTICED THE FILTER HAD COME OFF FROM THE NOZZLE OF THE PROCELL. CUSTOMER SUPPORT ADVISED THE CUSTOMER TO PUT IT BACK. AFTERWARD, THE CUSTOMER STATED THERE WERE QUESTIONABLE RESULTS FOR AN UNKNOWN NUMBER OF PATIENT SAMPLES THAT WERE GENERATED BEFORE THE ANALYZER ALARMS WERE RECEIVED. THE FOLLOWING DATA WAS PROVIDED: CARCINOEMBRYONIC ANTIGEN (CEA): INITIAL RESULT 6.99 NG/ML, REPEAT RESULT 18.8 NG/ML. INITIAL RESULT < 0.2 NG/ML, REPEAT RESULT 8.41 NG/ML. THYROTROPIN (TSH): INITIAL RESULT 1.55 UIU/ML, REPEAT RESULT 3.24 UIU/ML. FREE TRIIODOTHYRONINE (FT3): INITIAL RESULT 4.38 PG/ML, REPEAT RESULT 2.8 PG/ML. THE INITIAL RESULTS WERE REPORTED OUT OF THE LABORATORY, BUT NO ADVERSE EVENT OCCURRED AND NO CHANGES WERE MADE IN ANY PATIENTS' TREATMENTS. THE REAGENT LOT NUMBERS AND EXPIRATION DATES WERE NOT PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1