BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS ANALYZER

    MDR report key: 18327453 · Received December 14, 2023

    Report

    Report Number
    1823260-2023-04005
    Event Type
    Malfunction
    Date Received
    December 14, 2023
    Date of Event
    November 22, 2023
    Report Date
    January 31, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER PERFORMED MAINTENANCE, REPLACED THE FILTER, AND PERFORMED AN INTERNAL WATER CLEANING. THE CUSTOMER PERFORMED CALIBRATION, QC, AND A SAMPLE COMPARISON WHICH WERE ACCEPTABLE. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE. MEDWATCH FIELDS D1-D4, G1, AND G4 WERE UPDATED.

    Additional Manufacturer Narrative · 0

    THE ANALYZER SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE IRON GEN.2 RESULTS FROM THE COBAS INTEGRA 400 PLUS ANALYZER. SAMPLE 1 INITIAL RESULT WAS 6.98 UG/DL WITH A DATA FLAG AND A REPEAT RESULT OF 13 UG/DL. SAMPLE 2 INITIAL RESULT WAS 6.42 UG/DL WITH A DATA FLG AND A REPEAT RESULT OF 10 UG/DL. SAMPLE 3 INITIAL RESULT WAS 4.27 UG/DL WITH A DATA FLAG AND A REPEAT RESULT OF 11 UG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2340924 COBAS INTEGRA 400 PLUS ANALYZER CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 734537
    245301 COBAS INTEGRA 400 PLUS ANALYZER CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 734537

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown