BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E 801 MODULE

    MDR report key: 10326819 · Received July 27, 2020

    Report

    Report Number
    1823260-2020-01800
    Event Type
    Malfunction
    Date Received
    July 27, 2020
    Date of Event
    June 27, 2020
    Report Date
    August 19, 2020
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S INSTRUMENT ALARM TRACE AND QC TRACE HAD NO INDICATION FOR AN ISSUE. ALTHOUGH A CLEAR ROOT CAUSE COULD NOT BE IDENTIFIED BASED ON THE PROVIDED DATA, THE EVENT REPORTED BY THE CUSTOMER IS CONSISTENT WITH SIMILAR INCIDENCES PREVIOUSLY INVESTIGATED LEADING TO A POTENTIAL ROOT CAUSE OF E.G. PREANALYTICAL ISSUES AND/OR ANALYZER MAINTENANCE. BASED ON THE AVAILABLE INFORMATION, 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). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED QUESTIONABLE HIGH ELECSYS TROPONIN T HS RESULTS FOR TWO PATIENTS TESTED ON A COBAS 8000 E 801 MODULE. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER PERFORMED REPEAT TESTING FOR CONFIRMATION. ON (B)(6) 2020, PATIENT 1'S INITIAL TROPONIN RESULT WAS 15.9 NG/L. THE PATIENT'S REPEAT RESULTS WERE 12 NG/L AND 11.7 NG/L. ON (B)(6) 2020, PATIENT 2'S INITIAL TROPONIN RESULT WAS 24.9 NG/L. THE PATIENT'S REPEAT RESULTS WERE 14.4 NG/L AND 15.2 NG/L. TROPONIN REAGENT LOT WAS 47003401 WITH AN EXPIRATION DATE OF 31-JUL-2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793901 COBAS 8000 E 801 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E801 NA

    Patients

    Seq Age Sex Outcome Treatment
    1