BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 IMMUNOASSAY ANALYZER

    MDR report key: 6039696 · Received October 19, 2016

    Report

    Report Number
    1823260-2016-01589
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    September 9, 2016
    Report Date
    November 1, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY NAME CONTINUED - (B)(4). THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI)#: ASKU.

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED FOR INVESTIGATION BUT WAS NOT PROVIDED. BASED ON THE INFORMATION AVAILABLE FOR INVESTIGATION, A GENERAL REAGENT ISSUE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 1 PATIENT SAMPLE TESTED FOR THYROTROPIN (TSH). IT IS NOT KNOWN IF ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL TSH RESULT FROM THE E411 ANALYZER WAS 0.005 UIU/ML WITH A DATA FLAG. THE REPEAT RESULT FROM AN E601 ANALYZER WAS 2.47 UIU/ML. THE SAMPLE WAS REPEATED ON THE E411 ANALYZER AND THE RESULT WAS 0.005 UIU/ML WITH A DATA FLAG. ON (B)(6) 2016 THE SAMPLE WAS REPEATED ON THE E601 ANALYZER AND THE RESULT WAS 2.41 UIU/ML. NO ADVERSE EVENT OCCURRED. THE TSH REAGENT LOT NUMBER WAS 143583. THE EXPIRATION DATE WAS NOT PROVIDED. THE CUSTOMER THINKS THE ISSUE MAY HAVE BEEN CAUSED BY A LIQUID LEVEL DETECTION (LLD) ERROR ON THE E411 ANALYZER. THE CUSTOMER WAS ADVISED TO CLEAN THE SAMPLE/REAGENT PROBE EVERY DAY. THE CUSTOMER HAS NOT COMPLAINED OF ANY ADDITIONAL ISSUES SINCE THIS SUGGESTION WAS MADE. BASED ON A REVIEW OF THE ALARM TRACE, THE LLD ALARM OCCURRED ONLY FOR THE INITIAL RESULT FROM THE E411 ANALYZER. THE REPEAT RESULT FROM THE E411 ANALYZER DID NOT HAVE AN LLD ALARM ASSOCIATED WITH IT. POSSIBLE ROOT CAUSES FOR THIS EVENT MAY BE SAMPLE QUALITY, BUBBLES OR FOAM ON THE REAGENT, AND INSUFFICIENT MAINTENANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691268 COBAS E 411 IMMUNOASSAY ANALYZER IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E411 RACK NA

    Patients

    Seq Age Sex Outcome Treatment
    1