BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZER

    MDR report key: 6105820 · Received November 16, 2016

    Report

    Report Number
    1823260-2016-01781
    Event Type
    Malfunction
    Date Received
    November 16, 2016
    Date of Event
    October 31, 2016
    Report Date
    January 23, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPEAT RESULTS WERE RUN ON A COBAS 8000 E 602 MODULE. THE CUSTOMER CONSIDERS THE REPEAT RESULTS FROM THE E602 MODULE TO BE CORRECT.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED FOR INVESTIGATION BUT WAS NOT PROVIDED. DIFFERENCES IN RESULTS CAN BE CAUSED BY VARIOUS FACTORS. SINCE THE CUSTOMER STATED THE ISSUE HAS BEEN OCCURRING FOR "SOMETIME", A HARDWARE ISSUE IS MORE LIKELY. POTENTIAL ROOT CAUSES MAY BE RELATED TO IMPRECISION OF PIPETTING OR CONTAMINATION OF THE MEASURING CELL. THE ISSUE THE CUSTOMER COMPLAINED ABOUT WAS SOLVED AFTER A PREVENTIVE MAINTENANCE VISIT (PMV) BY THE FIELD SERVICE REPRESENTATIVE (FSR). THE POTENTIAL ROOT CAUSES MENTIONED WERE CHECKED DURING THE PMV. THE CUSTOMER HAS HAD NO FURTHER ISSUES SINCE THE SERVICE VISIT.

    Description of Event or Problem · 1

    THE CUSTOMER QUESTIONED HIGH RESULTS FOR MULTIPLE PATIENTS TESTED FOR FREE THYROXINE (FT4 II). THE CUSTOMER PROVIDED COMPARISON DATA FOR 4 PATIENTS THAT WERE ERRONEOUS. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL RESULTS WERE RUN ON A ROCHE DIAGNOSTICS ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZER AND THE REPEAT RESULTS WERE RUN ON A COBAS 8000 MODULAR ANALYZER SERIES INSTRUMENT. PATIENT 1 INITIAL FT4 II WAS 28.5 (UNIT OF MEASURE NOT PROVIDED). THE REPEAT RESULT WAS 17.40 (UNIT OF MEASURE NOT PROVIDED). PATIENT 2 INITIAL FT4 II RESULT WAS 27.9. THE REPEAT RESULT WAS 17.79. PATIENT 3 INITIAL FT4 II RESULT WAS 26.7. THE REPEAT RESULT WAS 18.48. PATIENT 4 INITIAL FT4 II RESULT WAS 39.6. THE REPEAT RESULT WAS 23.65 THE CUSTOMER ALSO STATED THAT THE ISSUE HAS PROBABLY BEEN AROUND FOR "SOMETIME." THE CUSTOMER STATED THEY ARE IN THE PROCESS OF REPEATING APPROXIMATELY 60 SAMPLES THAT WERE ORIGINALLY RUN ON (B)(6) 2016. THOSE INITIAL FT4 II RESULTS WOULD HAVE BEEN REPORTED OUTSIDE OF THE LABORATORY. NO INITIAL OR REPEAT RESULTS HAVE BEEN PROVIDED BY THE CUSTOMER. THIS INFORMATION HAS BEEN REQUESTED. NO ADVERSE EVENT OCCURRED. THE FT4 II REAGENT LOT NUMBER WAS 15822300. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE (FSR) VISITED THE CUSTOMER SITE AND RAN AN ANALYZER PERFORMANCE CHECK (APC) ON THE INSTRUMENT AND THE RESULTS WERE ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757448 ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZER IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E MODULE NA

    Patients

    Seq Age Sex Outcome Treatment
    1