BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 801 ANALYTICAL UNIT

    MDR report key: 17468698 · Received August 7, 2023

    Report

    Report Number
    1823260-2023-02533
    Event Type
    Malfunction
    Date Received
    August 7, 2023
    Date of Event
    July 13, 2023
    Report Date
    August 7, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    07613336158456
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANTI-HAV IGM REAGENT LOT NUMBER WAS 66399901 WITH AN EXPIRATION DATE OF 31-JUL-2023. AFTER THE CUSTOMER RECEIVED OUT-OF-RANGE QC RESULTS, THEY IDENTIFIED THE QUESTIONABLE RESULT. THE FIELD SERVICE ENGINEER (FSE) FOUND DAMAGED TUBING ON A REAGENT PIPETTER. AFTER REPLACING THE TUBING THE SYSTEM WORKED CORRECTLY. THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER COMPLAINED OF A DISCREPANT POSITIVE RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS ANTI-HAV IGM (ANTI-HAV IGM) ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 1.17 COI (POSITIVE). THE REPEAT RESULT WAS 0.16 COI (NEGATIVE). THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637586 COBAS E 801 ANALYTICAL UNIT IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 07613336158456

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown