BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 3073338 · Received April 23, 2013

    Report

    Report Number
    1823260-2013-02481
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    April 10, 2013
    Report Date
    May 7, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE. IT WAS NOTED THE CUSTOMER WAS USING A TOO SHORT CENTRIFUGATION TIME WHICH COULD CAUSE RESIDUAL CLOTS IN THE SAMPLE AND LEAD TO ERRONEOUS PIPETTING.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE CORTISOL RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT FROM AN ALIQUOT TUBE WAS 0.064 UG/DL WITH A DATA FLAG AND WAS REPORTED OUTSIDE THE LABORATORY AS <0.3 UG/DL. ON (B)(6) 2013, THE CUSTOMER NOTICED THIS RESULT AS THE RESULT FOR A NEW SAMPLE FROM THE PATIENT WAS 200 UG/DL. THE CUSTOMER PULLED THE SAMPLE FROM (B)(6) 2013 AND THE FIRST TESTING GAVE A DATA ALARM WITH NO RESULT. THE REPEAT RESULTS WERE 63.4 UG/DL WITH A DATA FLAG AND 68.83 UG/DL. THE REPORT WAS CORRECTED TO 68.8 UG/DL AND CALLED TO THE NURSING STATION. THE PATIENT HAD NOT BEEN TREATED ON THE <0.3 UG/DL RESULT. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE CORTISOL REAGENT LOT NUMBER WAS 16826702 WITH AN EXPIRATION DATE OF 09/30/2013. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DUPLICATE PROBLEM AND TOOK NO CORRECTIVE ACTIONS. HE RAN PERFORMANCE TESTING WITH RESULTS WITHIN STANDARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173460 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1