BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 3850569 · Received June 5, 2014

    Report

    Report Number
    1823260-2014-04030
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 19, 2014
    Report Date
    August 8, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPEATED THE ORIGINAL SAMPLE, AND THE RESULT WAS 0.794 MIU/ML. THE CUSTOMER REPEATED THE SECOND SAMPLE AND THE RESULT WAS 3.50 MIU/ML. THE FIELD SERVICE REPRESENTATIVE FOUND THE PINCH TUBING WAS NOT REPLACED PROPERLY.

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. THE CALIBRATION AND QUALITY CONTROL DATA WERE OK. A POSSIBLE REAGENT ISSUE COULD BE EXCLUDED. THE CUSTOMER STATED THE SERUM QUALITY WAS CHECKED AND THERE WERE NO VISIBLE FIBRIN OR CLOTS OBSERVED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE THYROTROPIN (TSH) RESULTS FOR ONE PATIENT ON THEIR E601 ANALYZER. THE PATIENT'S SAMPLE WAS PROCESSED ON THE CUSTOMER'S MODULAR PRE ANALYTICS DEVICE AND TESTED AS AN ALIQUOT. THE INITIAL RESULT WAS 47.49MIU/L. ON (B)(6) 2014, THE PATIENT HAD A SECOND SAMPLE DRAWN AND TESTED ON THE E601 ANALYZER. THE RESULT WAS 3.46 MIU/L. ON (B)(6) 2014, THE PATIENT'S PRIMARY TUBE WAS REPEATED ON THE INITIAL E601 ANALYZER AND THE RESULT WAS 0.793 MIU/L. ON (B)(6) 2014, THE PRIMARY TUBE WAS TESTED ON ANOTHER E601 ANALYZER AND THE RESULT WAS 0.815 MIU/L. THE FIRST SAMPLE WAS VISUALLY CHECKED. THE SAMPLE QUALITY WAS OK, AND THE SERUM WAS WELL SEPARATED FROM THE CELLS. THE CUSTOMER STATED THAT THE RESULTS FROM THE FIRST AND SECOND SAMPLE WERE REPORTED OUTSIDE THE LABORATORY. THE CLINICIAN WAS QUERYING WHICH RESULT IS THE CORRECT. THERE WERE NO ADVERSE EVENTS. THE TSH REAGENT LOT NUMBER WAS 176496. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329974 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JLW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 074 YR