BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 8868934 · Received August 7, 2019

    Report

    Report Number
    1823260-2019-02873
    Event Type
    Malfunction
    Date Received
    August 7, 2019
    Date of Event
    July 18, 2019
    Report Date
    September 23, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE DATA PROVIDED, A HARDWARE ISSUE COULD NOT BE CONFIRMED. THE CUSTOMER RETURNED A SAMPLE FOR INVESTIGATION. THE INVESTIGATION COULD NOT CONFIRM THE CUSTOMER¿S COMPLAINT. BASED ON THE INVESTIGATION, THE ISSUE IS CONSISTENT WITH A PATIENT SAMPLE ISSUE. DUE TO LIMITED DATA, A ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    A GENERAL REAGENT PROBLEM WAS RULED OUT BECAUSE CALIBRATION AND QUALITY CONTROL WERE ACCEPTABLE. THE INVESTIGATION IS ONGOING. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED QUESTIONABLE IRON2 IRON GEN.2 RESULTS FOR ONE PATIENT FROM THE COBAS INTEGRA 400 PLUS ANALYZER. THE SAMPLE WAS TESTED TWICE WITH INITIAL RESULTS OF 0 UG/DL. ON (B)(6) 2019, THE SAMPLE WAS REPEATED AND THE RESULT WAS 1 UG/DL. THE SAMPLE WAS SENT TO ANOTHER LABORATORY AND THE RESULT WAS 23.55 UG/DL. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE REAGENT LOT NUMBER WAS 38707901 WITH AN EXPIRATION DATE OF 31-JAN-2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664407 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS I400+ NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR