BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E 601 MODULE

    MDR report key: 11088957 · Received December 29, 2020

    Report

    Report Number
    1823260-2020-03417
    Event Type
    Malfunction
    Date Received
    December 29, 2020
    Date of Event
    December 4, 2020
    Report Date
    April 29, 2021
    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 · 0

    THE CUSTOMER'S CALIBRATION RESULTS WERE OK. THE CUSTOMER'S LEVEL 1 QC RESULTS WERE WITH 2 SD'S, BUT THE LEVEL 2 QC RESULTS WERE OUTSIDE OF 2 SD'S. THE INVESTIGATION REVIEWED THE SYSTEM'S ALARM TRACE AND NOTICED MULTIPLE ABNORMAL ASPIRATION, SAMPLE SHORT, AND LOWER REAGENT VOLUME ALARMS. THE FIELD SERVICE ENGINEER REINSTALLED SYSTEM SOFTWARE. HE PERFORMED PERFORMANCE TESTING WITH ACCEPTABLE RESULTS. AFTER SERVICE, NO FURTHER ISSUES WERE REPORTED. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER PERFORMED SYSTEM PERFORMANCE TESTING WITH FAILING RESULTS. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TSH ASSAY RESULTS FOR ONE PATIENT TESTED ON A COBAS 6000 E 601 MODULE. THE PATIENT'S INITIAL RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER PERFORMED REPEAT TESTING WITH THE PATIENT'S SAMPLE ON THE SAME ANALYZER FOR CONFIRMATION. THE PATIENT'S INITIAL TSH RESULT WAS 0.020 UIU/ML, AND THE PATIENT'S REPEAT RESULT WAS 2.28 UIU/ML. THE CUSTOMER DETERMINED THE REPEAT RESULT WAS CORRECT. THE TSH REAGENT LOT NUMBER WAS 466153 WITH AN EXPIRATION DATE OF 30-APR-2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1551127 COBAS 6000 E 601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1