BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 IMMUNOASSAY ANALYZER

    MDR report key: 7454178 · Received April 24, 2018

    Report

    Report Number
    1823260-2018-01262
    Event Type
    Malfunction
    Date Received
    April 24, 2018
    Date of Event
    April 3, 2018
    Report Date
    April 24, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). (B)(4). (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED FOR THE ELECSYS HCG + BETA TEST SYSTEM (HCGB) ON A COBAS E 411 IMMUNOASSAY ANALYZER. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED AS GREATER THAN 10000 MIU/ML. THE SAMPLE WAS DILUTED 1:20 AND REPEATED, RESULTING AS 101060 MIU/ML. THE SAMPLE WAS DILUTED 1:20 AND REPEATED A SECOND TIME, RESULTING AS 65800 MIU/ML. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE HCGB REAGENT LOT NUMBER WAS 210151. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER REPLACED TUBING ON THE ANALYZER AND NOW IT IS FUNCTIONING NORMALLY. PERFORMANCE TESTING WAS RUN ON THE ANALYZER AND IT WAS NORMAL. THE ISSUE WAS RESOLVED AFTER THESE ACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296687 COBAS E 411 IMMUNOASSAY ANALYZER IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E411 DISK NA

    Patients

    Seq Age Sex Outcome Treatment
    1