BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 601 MODULE

    MDR report key: 19811995 · Received July 23, 2024

    Report

    Report Number
    1823260-2024-02129
    Event Type
    Malfunction
    Date Received
    July 23, 2024
    Date of Event
    June 28, 2024
    Report Date
    August 15, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924714
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S QC AND CALIBRATION WERE ACCEPTABLE. THE FIELD SERVICE REPRESENTATIVE FOUND A MISALIGNED SAMPLE PROBE AND THE LIQUID LEVEL DETECTION SETTING WAS OUT OF SPECIFICATION. HE ALIGNED THE SAMPLE PROBE AND ADJUSTED THE LIQUID LEVEL DETECTION TO THE TARGET VALUE. A PRECISION CHECK WAS PERFORMED WITH ACCEPTABLE RESULTS AND ALL VALUES WERE WITHIN SPECIFICATION. THE CUSTOMER PERFORMED QC AND VERIFIED THE VALUES WERE WITHIN RANGE. AFTER SERVICE, NO ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER WAS 771985. THE EXPIRATION DATE WAS NOT PROVIDED. IT WAS NOTED THAT MICROCLOTS IN THE SAMPLE COULD BE POSSIBLE. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TROPONIN T GEN 5 STAT ASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 601 MODULE. THE INITIAL RESULT WAS 11.15 NG/L. THE REPEATED RESULT WAS 183.1 NG/L. THE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED AS THE NURSE QUESTIONED THE INITIAL RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2466414 COBAS E 601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630924714

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown