BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 IMMUNOASSAY ANALYZER

    MDR report key: 6109105 · Received November 17, 2016

    Report

    Report Number
    1823260-2016-01789
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Date of Event
    November 3, 2016
    Report Date
    November 17, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATED THEY RECEIVED ERRONEOUS RESULTS FOR 3 PATIENT SAMPLES TESTED FOR THE ELECSYS HCG + BETA TEST SYSTEM (HCGB) AND THE ELECSYS VITAMIN D ASSAY (VITD) ON THE COBAS E 411 IMMUNOASSAY ANALYZER. IT WAS ASKED, BUT IT IS NOT KNOWN IF ANY ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE FIRST SAMPLE INITIALLY RESULTED AS NEGATIVE WHEN TESTED FOR HCGB. THE PATIENT HAD A POSITIVE URINE TEST, SO THE SAMPLE WAS REPEATED. THE REPEAT RESULT WAS > 500 MIU/ML. THE SECOND SAMPLE INITIALLY RESULTED AS > 70 NG/ML FOR VITD. THE SAMPLE WAS REPEATED, RESULTING AS < 20 NG/ML FOR VITD. THE THIRD SAMPLE INITIALLY RESULTED AS > 70 NG/ML FOR VITD. THE SAMPLE WAS REPEATED, RESULTING AS < 20 NG/ML FOR VITD. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE HCGB AND VITD REAGENT LOT NUMBERS AND EXPIRATION DATES WERE REQUESTED, BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER CHECKED THE ANALYZER AND NO MALFUNCTION WAS OBSERVED. IT WAS CONCLUDED THE ISSUE WAS RELATED TO PRE-ANALYTIC SAMPLE HANDLING SINCE THE RESULTS WERE CORRECT AFTER CENTRIFUGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759609 COBAS E 411 IMMUNOASSAY ANALYZER IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E411 RACK NA

    Patients

    Seq Age Sex Outcome Treatment
    1