BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E 801 MODULE

    MDR report key: 9139494 · Received October 1, 2019

    Report

    Report Number
    1823260-2019-03514
    Event Type
    Malfunction
    Date Received
    October 1, 2019
    Date of Event
    September 4, 2019
    Report Date
    November 18, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SUSPECTED THAT THERE WAS EITHER FOAM OR BUBBLES ON TOP OF THE SAMPLE. THE CUSTOMER DID NOT HAVE THE SAMPLE FOAM DETECTION (SFD) CAMERA ACTIVATED ON THE COBAS E801 MODULE. THE COBAS E801 DOES NOT HAVE A PRESSURE SENSOR TO DETECT BUBBLES, THEREFORE THE SFD CAMERA HAS TO BE ACTIVATED TO DETECT BUBBLES. THE INVESTIGATION IS CURRENTLY ONGOING. THE EVENT OCCURRED IN: (B)(6).

    Description of Event or Problem · 1

    THE INITIAL REPORTER COMPLAINED OF QUESTIONABLE LOW ELECSYS TSH ASSAY, ELECSYS FT4 III ASSAY, ELECSYS FT3 III RESULTS FOR 1 PATIENT TESTED ON A COBAS 8000 E 801 MODULE. FROM THE DATA PROVIDED, THE FT4 II AND TSH DATA WERE DISCREPANT. THE INITIAL FT4 III RESULT WAS 1.3 PMOL/L WITH A DATA FLAG. THE INITIAL TSH RESULT WAS 0.031 MU/L. THE SAME PATIENT SAMPLE WAS RETESTED TWICE ON (B)(6) 2019 WITH FT4 III RESULTS OF 15.7 PMOL/L AND 15.3 PMOL/L AND TSH RESULTS OF 0.032 MU/L AND 1.63 MU/L RESPECTIVELY. THE RESULTS IN QUESTION WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS INITIALLY PROCESSED BY A MODULAR PRE-ANALYTICAL SYSTEM. THE FT4 III AND TSH REAGENT LOT INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932546 COBAS 8000 E 801 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E801 NA

    Patients

    Seq Age Sex Outcome Treatment
    1