BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 RACK SYSTEM

    MDR report key: 3971641 · Received July 31, 2014

    Report

    Report Number
    1823260-2014-05779
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 26, 2014
    Report Date
    August 8, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Additional Manufacturer Narrative · 1

    A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE FEED WATER PUMP WAS MOST LIKELY NOT DIRECTLY RELATED TO THIS EVENT. THE CALIBRATION AND QUALITY CONTROL RESULTS WERE WITHIN RANGE. NO SIMILAR ISSUES HAVE BEEN REPORTED FOR THIS LOT. THE ISSUE IS MOST LIKELY RELATED TO THE ON BOARD DILUENT. THE DILUENT HAD BEEN ON THE ANALYZER LONGER THAN THE STORAGE AND STABILITY CLAIMS DOCUMENTED IN PRODUCT LABELING.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE THYROTROPIN (TSH) RESULTS ON THEIR E411 ANALYZER. THE CUSTOMER STATED THEY SAW THE ISSUE WITH CAP SURVEY SAMPLES AND A PATIENT SAMPLE. THE CUSTOMER PROVIDED DATA FOR ONE PATIENT SAMPLE WITH A DISCREPANT RESULT. THE PATIENT'S INITIAL TSH RESULT WAS >100 UIU/ML ACCOMPANIED BY A DATA FLAG. THIS RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER PROGRAMMED THE ANALYZER TO DILUTE THE SAMPLE 1:10 AND THEN PUT THE SAMPLE BACK ON THE ANALYZER. THE RESULT WAS 0.430 UIU/ML. THIS RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THIS PATIENT SAMPLE WAS SENT TO A SISTER HOSPITAL THE SAME DAY AND IT WAS TESTED ON A COBAS 6000 ANALYZER. THE INITIAL RESULT FROM THE COBAS 6000 WAS >100 UIU/ML ACCOMPANIED BY A DATA FLAG, AND IT AS NOT REPORTED OUTSIDE THE LABORATORY. THE ANALYZER WAS THEN PROGRAMMED TO DILUTE THE SAMPLE 1:10 AND THE RESULT WAS 129.90 UIU/ML. THIS RESULT WAS CONSIDERED CORRECT AND IT WAS REPORTED OUTSIDE THE LABORATORY. THERE WERE NO ADVERSE EVENTS. THE TSH REAGENT LOT NUMBER WAS 17616003 AND THE EXPIRATION DATE WAS 09/30/2014. THE FIELD SERVICE REPRESENTATIVE FOUND THAT THE FEED WATER PUMP ASSEMBLY HAD FAILED CAUSING FLUID DISTRIBUTION FAILURES. HE REPLACED THE FEED WATER PUMP ASSEMBLY AND PRIMED. SUCCESSFUL PERFORMANCE TESTING WAS DONE. THE CUSTOMER PERFORMED QUALITY CONTROL WITH ALL RESULTS WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448340 COBAS E411 RACK SYSTEM IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1