BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 IMMUNOASSAY ANALYZER

    MDR report key: 6171829 · Received December 13, 2016

    Report

    Report Number
    1823260-2016-01955
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Date of Event
    December 1, 2016
    Report Date
    January 3, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED INFORMATION ABOUT THE DISCREPANT RESULTS WAS PROVIDED. THE INITIAL RESULT WAS 0.300 NG/ML, ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF 7.66 AND 7.46 NG/ML. THE 7.46 NG/ML RESULT WAS REPORTED OUTSIDE THE LABORATORY. SOME SAMPLE RACKS IN USE DID NOT HAVE RACK ADAPTERS FOR THE TUBE SIZE USED. SOME SAMPLE RACKS WERE MISSING A PART THE COULD HAVE CAUSED THE RACKS TO SIT TOO LOW DURING SAMPLING. EITHER OF THESE ISSUES COULD HAVE BEEN A CAUSE FOR THE ISSUE. THE FIELD SERVICE ENGINEER CHECKED THE INSTRUMENT, EXCHANGED TUBING, AND MADE ADJUSTMENTS. HE PERFORMED A VOLUME CHECK. AFTER THESE INTERVENTIONS THE CUSTOMER DID NOT COMPLAIN OF ANY MORE DISCREPANT RESULTS. FIBRIN WAS OBSERVED IN THE SAMPLE. THE ALARM TRACE, CALIBRATION, AND QUALITY CONTROL DATA DID NOT INDICATE AN ISSUE. A GENERAL REAGENT ISSUE CAN MOST LIKELY BE EXCLUDED. THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE WITH THE INFORMATION AVAILABLE. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE MOST LIKELY ROOT CAUSE WAS POOR SAMPLE QUALITY. ADDITIONALLY, AN INSTRUMENT-RELATED ROOT CAUSE CANNOT BE EXCLUDED DUE TO THE MAINTENANCE AND ADJUSTMENTS REQUIRED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ONE ERRONEOUS RESULT FROM A PATIENT SAMPLE TESTED WITH THE ELECSYS CK-MB STAT IMMUNOASSAY REAGENT. THE INITIAL RESULT WAS 0.3 NG/ML; THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULT WAS 7.6 NG/ML. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE REAGENT LOT NUMBER WAS 118409; THE EXPIRATION DATE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821187 COBAS E 411 IMMUNOASSAY ANALYZER IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E411 RACK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR