BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 RACK SYSTEM

    MDR report key: 4634655 · Received March 26, 2015

    Report

    Report Number
    1823260-2015-02437
    Event Type
    Malfunction
    Date Received
    March 26, 2015
    Date of Event
    March 7, 2015
    Report Date
    April 2, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. BASED ON THE PROVIDED CALIBRATION, QC AND INSTRUMENT DATA, GENERAL REAGENT OR INSTRUMENT ISSUES WERE NOT SUSPECTED. IT WAS NOTED THE CUSTOMER WAS NOT FOLLOWING THE TUBE MANUFACTURER'S RECOMMENDATION FOR SPECIMEN HANDLING WHICH MAY HAVE AFFECTED THE SAMPLE QUALITY AND CONTRIBUTED TO THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE INTACT HUMAN CHORIONIC GONADOTROPIN + THE B-SUBUNIT (HCG+B) RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 0.434 MUI/ML. THE REPEAT RESULT WAS > 10 000 MUI /ML WITH A DATA FLAG AND WITH A 1:100 DILUTION, THE RESULT WAS 11607 MUI/ML WITH A DATA FLAG. THE RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE HCG+B REAGENT LOT NUMBER WAS 183183. THE EXPIRATION DATE WAS REQUESTED, BUT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202342 COBAS E411 RACK SYSTEM IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 028 YR