BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 DISK SYSTEM

    MDR report key: 2920446 · Received January 17, 2013

    Report

    Report Number
    1823260-2013-00326
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 27, 2012
    Report Date
    January 17, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHX
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO INFORMATION WAS PROVIDED ON THE SPECIFIC PART NUMBER INVOLVED IN THIS EVENT. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE CARCINOEMBRYONIC ANTIGEN (CEA) RESULTS FOR THREE PATIENT SAMPLES. THE REAGENT PACK HAD BEEN USED ON A COBAS E411 ANALYZER AND THEN LOADED ONTO THE MODULAR E ANALYZER SERIAL NUMBER (B)(4). THE INITIAL RESULTS FROM THE MODULAR E ANALYZER WERE: PATIENT SAMPLE 1: 1.9 NG/ML. PATIENT SAMPLE 2: 0.9 NG/ML. PATIENT SAMPLE 3: 0.9 NG/ML. THE CUSTOMER NOTICED ONE OF THE RESULTS WAS FLAGGED, BUT COULD NOT PROVIDE INFORMATION ON WHICH RESULT WAS FLAGGED. THE CUSTOMER CHECKED THE REAGENT PACK AND FOUND THERE WAS A PIPETTE TIP FROM THE COBAS E411 INSIDE THE REAGENT PACK. THE REAGENT PACK WAS REPLACED AND THE SAMPLES WERE RETESTED ON THE MODULAR E ANALYZER. THE REPEAT RESULTS WERE: PATIENT SAMPLE 1: 6.1 NG/ML. PATIENT SAMPLE 2: 5.7NG/ML. PATIENT SAMPLE 3: 2.1 NG/ML. BOTH THE INITIAL AND REPEAT RESULTS WERE REPORTED TO THE PHYSICIANS. NO ADVERSE EVENT HAS BEEN REPORTED. THE CEA REAGENT LOT NUMBER WAS 167390 WITH AN EXPIRATION DATE OF 07/30/2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25499 COBAS E411 DISK SYSTEM IMMUNOCHEMISTRY ANALYZER DHX ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1