BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E 601 MODULE

    MDR report key: 8025091 · Received October 31, 2018

    Report

    Report Number
    1823260-2018-03983
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Date of Event
    August 2, 2018
    Report Date
    February 6, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924714
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY DID AN EVALUATION OF PATIENT SAMPLES TESTED FOR THE ELECSYS TROPONIN T HS STAT ASSAY (TNTHSST) ON TWO COBAS 6000 E 601 MODULE (E601) ANALYZERS. THIS EVALUATION WAS DONE TO DETERMINE THE NUMBER OF RESULT OUTLIERS IN PATIENT SAMPLES TESTED BETWEEN (B)(6) 2018 AND (B)(6) 2018. THE CUSTOMER PROVIDED DATA FOR A TOTAL OF 2432 PATIENT SAMPLES TESTED IN DUPLICATE FOR TNTHSST. OF THE 2432 PATIENT SAMPLES, 3 HAD ERRONEOUS RESULTS MEASURED ON ONE E601 ANALYZER THAT WERE REPORTED OUTSIDE OF THE LABORATORY. THE FIRST SAMPLE INITIALLY RESULTED AS 74.15 NG/L AND REPEATED AS 92.4 NG/L. THE SECOND SAMPLE INITIALLY RESULTED AS 16.48 NG/L ON (B)(6) 2018 AND REPEATED AS 19.85 NG/L. THE THIRD SAMPLE INITIALLY RESULTED AS 7.25 NG/L ON (B)(6) 2018 AND REPEATED AS 9.02 NG/L. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENTS. THE TNTHSST REAGENT LOT NUMBER WAS 267654. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867080 COBAS 6000 E 601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E601 NA 04015630924714

    Patients

    Seq Age Sex Outcome Treatment
    1