BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E 801 MODULE

    MDR report key: 10355170 · Received August 3, 2020

    Report

    Report Number
    1823260-2020-01861
    Event Type
    Malfunction
    Date Received
    August 3, 2020
    Date of Event
    July 9, 2020
    Report Date
    August 24, 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

    CONTROLS DID NOT SHOW ANY INDICATION OF AN ISSUE. UPON REVIEW OF THE ALARM TRACE, NO RELEVANT ALARMS WERE OBSERVED. THE INVESTIGATION COULD 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 INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH THE ELECSYS TROPONIN T HS ASSAY ON A COBAS 8000 E 801 MODULE. NO INCORRECT VALUES WERE REPORTED OUTSIDE OF THE LABORATORY. THE FIRST SAMPLE WAS TESTED IN A SAMPLE CUP, INITIALLY RESULTING WITH A TROPONIN T VALUE OF 19.7 NG/L. THE CUP WAS REPEATED, RESULTING WITH A VALUE OF 77.2 NG/L. THE PRIMARY TUBE OF THE SAMPLE WAS ALSO REPEATED, RESULTING WITH A VALUE OF 20.6 NG/L. THE SECOND SAMPLE WAS TESTED IN THE PRIMARY TUBE, INITIALLY RESULTING WITH A TROPONIN T VALUE OF 20.4 NG/L. THE TUBE WAS REPEATED, RESULTING WITH A VALUE OF 38.2 NG/L. THE TUBE WAS REPEATED A SECOND TIME, RESULTING WITH A VALUE OF 23.3 NG/L. THE TROPONIN T REAGENT LOT NUMBER WAS 470034. THE REAGENT EXPIRATION DATE WAS REQUESTED, BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818899 COBAS 8000 E 801 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E801 NA

    Patients

    Seq Age Sex Outcome Treatment
    1