BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E602 MODULE

    MDR report key: 3140368 · Received May 31, 2013

    Report

    Report Number
    1823260-2013-03290
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 31, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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 ANALYZER ALARMS AND DISCOVERED QUESTIONABLE RESULTS FOR VITAMIN B12 GENERATION 2 (B12), FREE THYROXINE (FT4), FOLATE GENERATION 3, AND A1-FETOPROTEIN (AFP) ON ABOUT 100 PATIENT SAMPLES THAT HAD BEEN PROCESSED BY THE MODULAR PREANALYTIC ANALYZER (MPA). THE INITIAL RESULTS WERE AUTO-VERIFIED AND REPORTED OUTSIDE THE LABORATORY. THE REPEAT TESTING WAS PERFORMED (B)(6) 2013. OF THE DATA PROVIDED, THE RESULTS FOR (B)(4) PATIENT SAMPLES WERE DISCREPANT. THE CUSTOMER CALLED EACH PHYSICIAN TO PROVIDE THE CORRECTED REPORT. NO PATIENTS WERE ADVERSELY AFFECTED. THE B12 REAGENT LOT NUMBER WAS 17094306 WITH AN EXPIRATION DATE OF 12/31/2013. THE FT4 REAGENT LOT NUMBER WAS 17127701 WITH AN EXPIRATION DATE OF 02/28/2014. THE FOLATE REAGENT LOT NUMBER WAS 16971501 WITH AN EXPIRATION DATE OF 10/31/2013. THE AFP REAGENT LOT NUMBER WAS 16921401 WITH AN EXPIRATION DATE OF 02/28/2014. THE FIELD SERVICE REPRESENTATIVE FOUND THE SIPPER PROBE WAS LEAKING AND IT WAS REPLACED. NO LEAKS, PROBLEMS OR SYSTEM PERFORMANCE ISSUES WERE FOUND. HE RAN PERFORMANCE TESTING, CALIBRATION AND CONTROLS WHICH ALL PASSED IN RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241892 COBAS 8000 E602 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1