BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E 601 MODULE

    MDR report key: 7490333 · Received May 7, 2018

    Report

    Report Number
    1823260-2018-01397
    Event Type
    Malfunction
    Date Received
    May 7, 2018
    Date of Event
    April 18, 2018
    Report Date
    May 7, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI)#: (B)(4). THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF QUESTIONABLE ELECSYS CA 19-9 IMMUNOASSAY (CA 19-9) RESULTS FOR ONE PATIENT SAMPLE ON A COBAS 6000 E 601 MODULE. THE INITIAL CA 19-9 RESULT WAS 256 U/ML AND THE REPEAT RESULT WAS 8.6 U/ML. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT BECAUSE THE PATIENT DID NOT HAVE SYMPTOMS. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE OTHER PATIENT SAMPLES WERE ACCEPTABLE. THE CALIBRATION AND QC WERE ACCEPTABLE. THE REAGENT LOT NUMBER WAS 231612 WITH AN EXPIRATION DATE OF 31-OCT-2018. THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE AND A GENERAL PRODUCT PROBLEM WAS EXCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333554 COBAS 6000 E 601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1