BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E 601 MODULE

    MDR report key: 7548982 · Received May 29, 2018

    Report

    Report Number
    1823260-2018-01632
    Event Type
    Malfunction
    Date Received
    May 29, 2018
    Date of Event
    May 3, 2018
    Report Date
    May 29, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF QUESTIONABLE ELECSYS FT3 III RESULTS FOR 3 PATIENT SAMPLES TESTED ON A COBAS 6000 E601 MODULE. REPEAT TESTING WAS PERFORMED ON (B)(6) 2018 AFTER THE FIELD ENGINEERING SPECIALIST CHANGED THE MEASURING CELL. PATIENT 1 INITIAL FT3 III RESULT WAS 29.29 PMOL/L AND REPEAT RESULT WAS 5.35 PMOL/L. PATIENT 2 INITIAL FT3 III RESULT WAS 15.55 PMOL/L AND REPEAT RESULT WAS 4.95 PMOL/L. PATIENT 3 INITIAL FT3 III RESULT WAS 32.76 PMOL/L AND REPEAT RESULT WAS 5.68 PMOL/L. THE ERRONEOUS RESULTS WERE NOT RELEASED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE FT3 III REAGENT LOT WAS 277945 WITH AN EXPIRATION DATE THAT WAS REQUESTED BUT NOT PROVIDED. FURTHER INVESTIGATION SHOWED THAT QC RESULTS ON THE DAY OF EVENT WERE GOOD. THE FIELD ENGINEERING SPECIALIST FINDING WAS DETERMINED TO BE THE ROOT CAUSE. AFTER REPLACEMENT OF THE MEASURING CELL, THE FIELD ENGINEERING SPECIALIST PERFORMED PERFORMANCE TESTING. THE ANALYZER HAS BEEN WORKING PROPERLY FOLLOWING THE CELL REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390713 COBAS 6000 E 601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1