BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 IMMUNOASSAY ANALYZER

    MDR report key: 6129841 · Received November 28, 2016

    Report

    Report Number
    1823260-2016-01853
    Event Type
    Malfunction
    Date Received
    November 28, 2016
    Date of Event
    October 3, 2016
    Report Date
    January 5, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION REVIEWED THE ANALYZER PERFORMANCE CHECK DATA AND NO ISSUES WERE IDENTIFIED. ALL RESULTS WERE ACCEPTABLE. A SPECIFIC ROOT CAUSE WAS NOT IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED FOR INVESTIGATION BUT WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED THAT "ALL" CARDIAC TESTS WERE GIVING ERRATIC RESULTS. THE CUSTOMER PROVIDED ERRONEOUS RESULTS FOR ELECSYS CK-MB (CK-MB), N-TERMINAL PRO B-TYPE NATRIURETIC PEPTIDE (PROBNP) AND TROPONIN T HS (HIGH SENSITIVE) TROPONIN T HS. IT IS UNCLEAR IF THESE RESULTS ARE FOR 1 PATIENT OR MULTIPLE PATIENTS. THIS INFORMATION HAS BEEN REQUESTED. THE DATE OF EVENT IS NOT CLEAR. THIS INFORMATION HAS BEEN REQUESTED. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2016 ,THE INITIAL CK-MB RESULT WAS 0.6 NG/ML. THE REPEAT RESULT WAS 6.1 NG/ML. ON (B)(6) 2016, THE INITIAL TROPONIN T HS RESULT WAS 12 PG/ML. THE REPEAT RESULT WAS 20 PG/ML. ON (B)(6) 2016, THE INITIAL PROBNP RESULT WAS 15 PG/ML. THE REPEAT RESULT WAS 9778 PG/ML. A FERRITIN RESULT OF 13.14 NG/ML FROM (B)(6) 2016 WAS PROVIDED. IT IS NOT CLEAR HOW THIS RESULT IS RELATED TO THIS EVENT OR IF THIS IS AN ADDITIONAL RESULT FOR THE PATIENT OR PATIENTS INVOLVED. CLARIFICATION ON THIS HAS BEEN REQUESTED. NO ADVERSE EVENT OCCURRED. THE CK-MB REAGENT LOT NUMBER WAS 118409. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED. THE PROBNP REAGENT LOT NUMBER WAS 141292 WITH AN EXPIRATION DATE OF 08/2017. THE TROPONIN T HS REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE. MULTIPLE PARTS OF THE INSTRUMENT WERE CHECKED, ADJUSTED OR REPLACED. THE SYSTEM REAGENT COMPARTMENT WAS REPLACED. SAMPLE RACK INSERTS WERE DAMAGED. THESE WERE REPLACED. THE SAMPLE/REAGENT PROBE LIQUID LEVEL DETECTION VOLTAGE WAS FOUND TO BE OUT OF RANGE. THIS WAS ADJUSTED. AN ANALYZER PERFORMANCE CHECK (APC) WAS RUN AND THE RESULTS WERE ON THE HIGH END. THE MEASURING CELL AND TUBINGS WERE REPLACED. THE APC WAS REPEATED AND THE RESULTS WERE ACCEPTABLE. THE CUSTOMER HAS HAD NO FURTHER ERRATIC RESULTS SINCE THE SERVICE ACTION PERFORMED BY THE FSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780197 COBAS E 411 IMMUNOASSAY ANALYZER IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E411 DISK NA

    Patients

    Seq Age Sex Outcome Treatment
    1