BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E 801 MODULE

    MDR report key: 7751631 · Received August 6, 2018

    Report

    Report Number
    1823260-2018-02613
    Event Type
    Malfunction
    Date Received
    August 6, 2018
    Date of Event
    July 18, 2018
    Report Date
    April 18, 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

    CALIBRATIONS FOR FT4 AND TSH WERE NOT ACCEPTABLE. THE CUSTOMER IS NOT FOLLOWING THE MANUFACTURER'S RECOMMENDED CALIBRATION SCHEDULE. BASED ON ACCEPTABLE QC RECOVERY, THERE WAS NO INDICATION OF A REAGENT OR INSTRUMENT PERFORMANCE ISSUE. THE ALARM TRACE DID NOT INDICATE AN ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THE ROOT CAUSE OF THIS EVENT IS DETERIORATION OF SYSTEM REAGENT PROCELL II M. 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 · 1

    THIS EVENT OCCURRED IN (B)(6). - (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE ELECSYS TSH ASSAY AND ELECSYS FT4 II ASSAY RESULTS FOR ONE PATIENT FROM A COBAS E 801 MODULE. FROM AN ALIQUOT OF THE SAMPLE, THE INITIAL TSH RESULT WAS 1.17 MIE/L AND INITIAL FT4 RESULT WAS 31.2 PMOL/L. THESE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND WERE QUESTIONED BY THE DOCTOR. ON (B)(6) 2018, THE PRIMARY SAMPLE TUBE WAS REPEATED ON THE SAME COBAS ANALYZER. THE TSH RESULT WAS 2.28 MIE/L AND FT4 RESULT WAS 16.6 PMOL/L. THE PRIMARY SAMPLE TUBE WAS ALSO REPEATED ON ANOTHER COBAS ANALYZER. THE TSH RESULT WAS 2.38 MIE/L AND FT4 RESULT WAS 16.5 PMOL/L. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE TSH REAGENT LOT NUMBER WAS 283556 WITH AN EXPIRATION DATE OF 02/28/2019. THE FT4 REAGENT LOT NUMBER WAS 303203 WITH AN EXPIRATION DATE OF 04/30/2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595204 COBAS 8000 E 801 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E801 NA 04015630946198

    Patients

    Seq Age Sex Outcome Treatment
    1