BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 2027078 · Received March 23, 2011

    Report

    Report Number
    1823260-2011-01564
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 23, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE INTACT HUMAN CHORIONIC GONADOTROPIN + SS- SUBUNIT (HCG) RESULTS FOR ONE PATIENT. ALL RESULTS ARE IN MIU/ML. THE INITIAL RESULT WAS 0.100 WITH A DATA FLAG FROM THE COBAS E601 SERIAL NUMBER (B)(4) WHICH WAS REPORTED OUTSIDE THE LABORATORY AND WAS QUESTIONED BY DOCTOR. THE USER REPEATED THE SAME SAMPLE ON THE ELECSYS 2010 WITH A 1:100 DILUTION AND THE RESULT WAS 48.08 WITH A DATA FLAG. THE USER REPEATED THE SAMPLE UNDILUTED WITH A RESULT OF 35.55 WITH A DATA FLAG. THE DOCTOR WAS TESTING THE PATIENT FOR PREGNANCY PURPOSES, SO A SECOND PLASMA SAMPLE WAS DRAWN FROM THE PATIENT. THE RESULT WAS <0.100 WITH A DATA FLAG, AND 25.01 WITH A DATA FLAG ON A 1:100 DILUTION. THE RESULT FROM THE COBAS E601 WAS <0.1. THE FIRST SAMPLE WAS RETESTED ON THE 2010 ABOUT TWO HOURS AFTER THE FIRST TESTING, AND THE RESULT WAS 35.94. THE USER TESTED URINE AND PLASMA SAMPLES FROM THE PATIENT WITH THE WAMPOLE QUALITATIVE KIT HCG TEST AND GOT NEGATIVE RESULTS ON BOTH SAMPLES. ON (B)(6) 2010, THE USER REPEATED THE FIRST SAMPLE AFTER THE PROBE WAS ADJUSTED WITH A RESULT "IN THE 40'S". NO SPECIFIC RESULT WAS PROVIDED. THE USER CONSIDERED THE RESULTS OF NEGATIVE, 0.1 AND <0.1 TO BE THE CORRECT RESULTS. ONLY THE INITIAL RESULT OF 0.1 FROM THE COBAS E601 WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE HCG REAGENT LOT NUMBER WAS 16015003. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE SIPPER PROBE WAS RUBBING THE SIDE OF THE ASSAY CUP AS IT DESCENDED. HE ADJUSTED THE SIPPER PROBE X AXIS, RAN A SYSTEM VOLUME CHECK AND RAN A LIQUID FLOW CLEANING EXERCISE. TO VERIFY THE ANALYZER OPERATION, HE RAN PERFORMANCE TESTING AND THE USER RAN QUALITY CONTROL WHICH RECOVERED IN RANGE. PRECISION TESTING WAS ALSO PERFORMED WHICH WAS PRECISE AND ACCURATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 2010 RACK IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 017 YR