BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E 801 MODULE

    MDR report key: 7841848 · Received September 4, 2018

    Report

    Report Number
    1823260-2018-02951
    Event Type
    Malfunction
    Date Received
    September 4, 2018
    Date of Event
    August 13, 2018
    Report Date
    April 23, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630946198
    PMA / PMN Number
    K060373
    Removal / Correction Number
    1823260-03/15/19-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERVICE ENGINEER OBSERVED THE MEASURING CELL WAS AGED AND THE REAGENT PROBE WAS BENT. ALL CUSTOMERS HAVE BEEN PROVIDED A WORKAROUND PROCEDURE TO PRIME THE INSTRUMENT WHEN IT IS DETERMINED THAT THEIR COBAS E 801 MODULE IS POTENTIALLY AFFECTED BY THIS ISSUE. THEY ARE ALSO INSTRUCTED TO CONTACT ROCHE TECHNICAL SUPPORT. A ROCHE FIELD SERVICE ENGINEER WILL PERFORM THE PROCELL II M FLOWPATH DECONTAMINATION PROCEDURE AND THE PROCEDURE SHOULD BE PERFORMED EVERY 4 WEEKS UNTIL YOUR COBAS E 801 MODULE IS SWITCHED TO THE IMPROVED PROCELL II M FORMULATION. IMPROVED PROCELL II M IS AVAILABLE IN THE US AND ROCHE FIELD SERVICE ENGINEERS ARE IN THE PROCESS OF CONVERTING CUSTOMERS TO THE NEW PROCELL II M.

    Additional Manufacturer Narrative · 0

    THE PROCELL FLOW-PATH WAS DECONTAMINATED. THE CUSTOMER HAS NOT HAD ANY ADDITIONAL ISSUES SINCE THIS WAS PERFORMED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER QUESTIONED RESULTS FOR MULTIPLE PATIENTS TESTED FOR ELECSYS FT4 III (FT4 III) AND TSH ON A COBAS E801 MODULE. BASED ON THE DATA PROVIDED, THE FT4 III RESULTS FOR 4 PATIENT SAMPLES WERE DISCREPANT. PATIENT 1 INITIAL FT4 III RESULT WAS 32.1 PMOL/L. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2018 THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF 18.4 PMOL/L AND 17.5 PMOL/L. ON (B)(6) 2018 PATIENT 2 INITIAL FT4 III RESULT WAS 30.1 PMOL/L. THIS RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS 21 PMOL/L. ON (B)(6) 2018 THE FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE WHERE "SLIME" WAS NOTED ON THE INSIDE OF THE PROCELL SYRINGE AND THERE WERE WHITE FLAKES FLOATING IN IT. THE FSE CLEANED THIS AND CHECKED THE PROBE ADJUSTMENTS. ONE REAGENT PROBE WAS BENT AND THE FSE CORRECTED THIS. ALL OTHER PROBES WERE OK. INSTRUMENT CHECKS PASSED AFTERWARDS. AFTER THE SERVICE VISIT, THE CUSTOMER STILL HAD ISSUES. ON (B)(6) 2018 PATIENT 3 INITIAL FT4 III RESULT WAS 15.5 PMOL/L. THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF 24 PMOL/L AND 16.8 PMOL/L. ON (B)(6) 2018 PATIENT 4 INITIAL FT4 III RESULT WAS 16.2 PMOL/L. THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF 25.7 PMOL/L AND 16.7 PMOL/L. IT IS NOT KNOWN IF ERRONEOUS RESULTS FOR PATIENTS 3 AND 4 WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED FOR ANY PATIENT. THE FT4 III REAGENT LOT NUMBER WAS 30469400. THE EXPIRATION DATE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683219 COBAS 8000 E 801 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E801 NA 04015630946198

    Patients

    Seq Age Sex Outcome Treatment
    1