BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 4232858 · Received November 6, 2014

    Report

    Report Number
    1823260-2014-08660
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 22, 2014
    Report Date
    November 25, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CORTISOL REAGENT LOT NUMBER WAS 174778.

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. A PREANALYTIC ISSUE WAS SUSPECTED AS IT WAS NOTED THE CUSTOMER WAS NOT USING THE REQUIRED CUP ADAPTERS ON THE SAMPLE RACK AND THE CENTRIFUGATION SETTINGS WERE NOT IN ACCORDANCE WITH THE MANUFACTURER'S SUGGESTIONS.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE CORTISOL RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 1.86 NMOL/L AND WAS REPORTED OUTSIDE THE LABORATORY. THE DOCTOR QUESTIONED THE RESULT AND THE SAMPLE WAS REPEATED. THE REPEAT RESULT WAS 657 NMOL/L. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE CORTISOL REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED, BUT WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714032 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 020 YR