BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E 801 MODULE

    MDR report key: 20567249 · Received October 30, 2024

    Report

    Report Number
    1823260-2024-03127
    Event Type
    Malfunction
    Date Received
    October 30, 2024
    Date of Event
    October 4, 2024
    Report Date
    November 1, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630946198
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CORTISOL ASSAY LOT NUMBER WAS 787762. THE EXPIRATION DATE WAS NOT PROVIDED. THE CUSTOMER MENTIONED THAT THEY HAD MULTIPLE QC FAILURES ON THE WEEK OF THE EVENT. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    ALL MAINTENANCE ITEMS WERE UP TO DATE. NO SAMPLE FOAM DETECTION (SFD) ALARMS WERE VISIBLE WITHIN THE LAST 30 DAYS WHICH IS CONSISTENT WITH HAVING THE SFD FEATURE DEACTIVATED. THE QC WAS WITHIN THE ACCEPTABLE LIMITS AND THE ALARM HISTORY DID NOT REVEAL ANY ISSUE WITH THE HARDWARE COMPONENTS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SERUM SAMPLE TESTED WITH ELECSYS CORTISOL ASSAY ON A COBAS E801 IMMUNOASSAY ANALYZER. INITIAL RESULT: 5 NMOL/L. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE INITIAL RESULT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS AND THE SAMPLE WAS REPEATED A FEW HOURS LATER. 1ST REPEAT RESULT: 356 NMOL/L. ON (B)(6) 2024 THE SAMPLE WAS REPEATED AND THE 2ND REPEAT RESULT WAS 355 NMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1782151 COBAS 8000 E 801 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E801 04015630946198

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown