BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 801 ANALYTICAL UNIT

    MDR report key: 18627327 · Received February 1, 2024

    Report

    Report Number
    1823260-2024-00300
    Event Type
    Malfunction
    Date Received
    February 1, 2024
    Date of Event
    January 9, 2024
    Report Date
    February 9, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    07613336158456
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CA 19-9 REAGENT LOT NUMBER WAS 708245 WITH AN EXPIRATION DATE OF 30-SEP-2024. THE AFP REAGENT LOT NUMBER WAS 714211 WITH AN EXPIRATION DATE OF 31-OCT-2024. THE CA 125 II REAGENT LOT NUMBER WAS 717472 WITH AN EXPIRATION DATE OF 31-OCT-2024. THE CEA REAGENT LOT NUMBER WAS 725519 WITH AN EXPIRATION DATE OF 30-SEP-2024. THE HE4 REAGENT LOT NUMBER WAS 738513 WITH AN EXPIRATION DATE OF 31-JAN-2025.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE SAMPLE FOAM DETECTION IMAGES SHOWED SEVERAL SAMPLES THAT WERE INSUFFICIENTLY CLOTTED AND SEVERAL SAMPLES WITH FIBRIN IN THE SUPERNATANT. BOTH OF THESE ISSUES CAN LEAD TO CLOGGED SAMPLE PROBES. THE INVESTIGATION DETERMINED THE EVENT WAS DUE TO PRE-ANALYTICAL HANDLING ISSUES (POOR SAMPLE QUALITY).

    Description of Event or Problem · 0

    THE INITIAL REPORTER QUESTIONED LOW RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED FOR MULTIPLE ASSAYS ON A COBAS E 801 ANALYTICAL UNIT. BASED ON THE DATA PROVIDED, DISCREPANT RESULTS WERE IDENTIFIED FOR 7 PATIENT SAMPLES TESTED FOR ELECSYS CA 19-9 (CA 19-9), ELECSYS AFP ASSAY (AFP), ELECSYS CA 125 II (CA 125 II), ELECSYS CEA (CEA) AND ELECSYS HE4 (HE4). REFER TO THE ATTACHED DATA FOR THE DISCREPANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1596168 COBAS E 801 ANALYTICAL UNIT IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 07613336158456

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown