BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 DISK SYSTEM

    MDR report key: 4221226 · Received November 3, 2014

    Report

    Report Number
    1823260-2014-08488
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 18, 2014
    Report Date
    November 17, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED INFORMATION WAS RECEIVED. THE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE PERFORMED THE FOLLOWING ACTIONS ON THE INSTRUMENT: REPLACED A CRACKED VALVE BODY, CHANGED TUBING AS PART OF YEARLY MAINTENANCE, FOUND AND FIXED DIRT PRESENT ON THE GRIPPER FINGERS, PERFORMED PMT HIGH VOLTAGE, PERFORMED INITIAL BLANK CELL CALIBRATION, AND EXCHANGED THE MEASURING CELL. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. POSSIBLE ROOT CAUSES ARE RELATED TO PRE-ANALYTIC SAMPLE HANDLING. IT WAS DETERMINED THAT NO TUBE INVERSIONS WERE PERFORMED, CLOTTING TIME WAS TOO SHORT, AND CENTRIFUGATION TIME WAS TOO SHORT. THE SERVICE ACTIONS MAY HAVE ALSO FIXED AN ISSUE WHICH MIGHT HAVE LED TO INTERMITTENT FALSE LOW RESULTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR THE MB ISOENZYME OF CREATINE KINASE (CK-MB). THE SAMPLE INITIALLY RESULTED AS 10.45 NG/ML ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED IN ORDER TO CONFIRM THE RESULT AND IT RESULTED AS 3.33 NG/ML. THE 3.33 NG/ML VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. A NEW SAMPLE WAS THEN DRAWN FROM THE PATIENT AND REPEATED FOUR TIMES ON THE SAME ANALYZER, RESULTING AS 12.07 NG/ML, 12.09 NG/ML, 11.98 NG/ML, AND 11.39 NG/ML. THEY SENT THE SAMPLE TO ANOTHER LAB FOR TESTING AND IT RESULTED AS 13.00 U/L. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE CK-MB REAGENT LOT NUMBER WAS 174104. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703750 COBAS E411 DISK SYSTEM IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 045 YR