BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTISOL

    MDR report key: 2098145 · Received May 20, 2011

    Report

    Report Number
    1823260-2011-02623
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 24, 2011
    Report Date
    July 22, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NHG
    PMA / PMN Number
    K070788
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THE CAUSE TO BE THE LEAKING DETECTION UNIT WHICH WAS DISCOVERED BY THE FIELD SERVICE REPRESENTATIVE. HE FOUND LIQUID HAD LEAKED ON A PCB BOARD AND CHANGED THE BOARD. THE ISSUE WAS SOLVED BY THE REPLACEMENT OF THE WHOLE DETECTION UNIT. NO PATIENTS WERE AFFECTED IN ANY WAY.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE CORTISOL RESULTS FOR AN UNKNOWN NUMBER OF PATIENT SAMPLES FROM THE COBAS E601 ANALYZER SERIAL NUMBER (B)(4). OF THE PROVIDED DATA, THE RESULTS FOR ONE PATIENT SAMPLE WERE DISCREPANT AND REPORTED OUTSIDE THE LABORATORY. THE INITIAL RESULT WAS >63.44 UG/DL AND THE REPEAT RESULT ON (B)(6) 2011 WAS 97.89 UG/DL. NO ADVERSE EVENTS WERE ALLEGED REGARDING THE ISSUE. UPON EVALUATION OF THE ANALYZER, THE FIELD SERVICE REPRESENTATIVE DETERMINED THE DETECTION UNIT WAS DAMAGED DUE TO FLUID. HE REPLACED THE DETECTION UNIT AND VERIFIED THE ANALYZER OPERATION BY RUNNING PERFORMANCE TESTING WITH RESULTS WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORTISOL ENZYME IMMUNOASSAY, CORTISOL, SALIVARY NHG ROCHE DIAGNOSTICS NA 16130602

    Patients

    Seq Age Sex Outcome Treatment
    1 075 YR