BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 5156836 · Received October 16, 2015

    Report

    Report Number
    1823260-2015-04349
    Event Type
    Malfunction
    Date Received
    October 16, 2015
    Date of Event
    October 2, 2015
    Report Date
    November 17, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. THE CUSTOMER WAS USING SECONDARY 13X75 MM TUBES WHICH ARE NOT RECOMMENDED. MAINTENANCE WAS NOT PERFORMED ON THE ANALYZER ACCORDING TO MANUFACTURER RECOMMENDATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER QUESTIONED RESULTS FROM 5 PATIENTS TESTED FOR EITHER THYROTROPIN (TSH), CYFRA 21-1, TESTOSTERONE (TESTOSTERONE II), OR FT3 - FREE TRIIODOTHYRONINE (FT3 III). BASED ON THE DATA PROVIDED, ERRONEOUS TSH AND FT3 III RESULTS WERE IDENTIFIED. ONE PATIENT WAS TESTED FOR TSH AND ONE PATIENT WAS TESTED FOR FT3 III. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. PATIENT 1 INITIAL TSH RESULT WAS 1.02 UIU/ML. THE REPEAT RESULT WAS 1.68 UIU/ML. PATIENT 2 INITIAL FT3 III RESULT WAS 1.7 PG/ML. THE REPEAT RESULT WAS 3.1 PG/ML. NO ADVERSE EVENT OCCURRED. THE TSH REAGENT LOT NUMBER WAS 186663. THE EXPIRATION DATE WAS NOT PROVIDED. THE FT3 III REAGENT LOT NUMBER WAS 183221. THE EXPIRATION DATE WAS NOT PROVIDED. THE FIELD SERVICE ENGINEER VISITED THE CUSTOMER SITE AND CHECKED THE PERFORMANCE OF THE ANALYZER. IT WAS NOTED THAT SAMPLE PROBE CLEANING HAD NEVER BEEN PERFORMED. MANY SAMPLE ALARMS HAD BEEN ISSUED. AFTER THIS VISIT THE LIQUID LEVEL DETECTION ALARMS WERE RESOLVED. IT WAS NOTED THAT THE CUSTOMER IS USING SECONDARY RIA 13X75 TUBES WITH RACK ADAPTERS. SERUM IS TRANSFERRED FROM THE PRIMARY TUBES INTO THESE SECONDARY TUBES. IT IS RECOMMENDED TO USE PRIMARY 13X75 SAMPLE TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687587 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1