BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E 801 MODULE

    MDR report key: 8663405 · Received June 3, 2019

    Report

    Report Number
    1823260-2019-02046
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    May 11, 2019
    Report Date
    June 3, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) DID NOT FIND A CAUSE FOR THE ISSUE. THE FLUIDICS WERE CHECKED ALONG WITH THE RINSE/WASH STATION LEVEL. GEAR PUMP PRESSURE WAS ALSO CHECKED. THE FSE USED CONTROLS TO PERFORM A COMPARISON BETWEEN 2 MODULES AND THE CUSTOMER RAN QC. ALL RESULTS WERE WITHIN THE SPECIFIED RANGES. CALIBRATION SIGNALS WERE SLIGHTLY LOWER THAN EXPECTED. QC WAS ACCEPTABLE. NEITHER A GENERAL INSTRUMENT OR REAGENT ISSUE WERE IDENTIFIED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS VITAMIN B12 II (VITAMIN B12 II) ON A COBAS E801 MODULE. THE INITIAL RESULT WAS 150 PG/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY WHERE THE PHYSICIAN QUESTIONED THE RESULT AND REQUESTED A NEW SAMPLE BE DRAWN. THE RESULT FROM THE 2ND SAMPLE WAS 2000 PG/ML AND WAS MORE IN LINE WITH THE PATIENT'S TYPICAL VITAMIN B12 II RESULTS. THE ORIGINAL SAMPLE WAS REPEATED WITH A RESULT OF 2903 PG/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AS A CORRECTED RESULT. NO ADVERSE EVENT OCCURRED. THE VITAMIN B12 II REAGENT LOT NUMBER WAS 37176001 WITH AN EXPIRATION DATE OF 31-JUL-2020. THE CUSTOMER DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455759 COBAS 8000 E 801 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E801 NA

    Patients

    Seq Age Sex Outcome Treatment
    1