BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010

    MDR report key: 3153107 · Received June 8, 2013

    Report

    Report Number
    1823260-2013-03433
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 28, 2013
    Report Date
    June 18, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LTJ
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. BASED UPON THE INFORMATION PROVIDED FOR INVESTIGATION, THE ISSUE WAS MOST LIKELY DUE TO MIS-USE OF THE SYSTEM AND PROCELL.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURED IN (B)(6). NO INFORMATION WAS PROVIDED ON THE SPECIFIC PART NUMBER INVOLVED IN THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE TOTAL PROSTATE-SPECIFIC ANTIGEN (TPSA) AND FREE PSA RESULTS ON THEIR 2010 ANALYZER. THE CUSTOMER PROVIDED DATA FOR FOUR PATIENTS, OF WHICH TWO HAD DISCREPANT TPSA RESULTS THAT MIGHT HAVE BEEN REPORTED OUTSIDE THE LABORATORY. THE FIRST PATIENT'S INITIAL TPSA RESULT WAS 0.846 NG/ML AND IT WAS REPORTED OUTSIDE THE LABORATORY. ON (B)(6) 2013, THE REPEAT RESULT WAS 3.02 NG/ML. THE PATIENT WAS THEN CONTACTED AND THE REPEAT RESULT WAS ISSUED AS A CORRECTED REPORT. ON (B)(6) 2013, THE SECOND PATIENT, A (B)(6) MALE, RECEIVED TPSA RESULTS OF 0.829 NG/ML AND 4.65 NG/ML. IT WAS UNCLEAR WHICH WAS THE INITIAL RESULT. THE CUSTOMER STATED 4.65 NG/ML WAS REPORTED OUTSIDE THE LABORATORY. IT WAS UNKNOWN IF THERE WERE ANY ADVERSE EVENTS. THE TPSA REAGENT LOT NUMBER WAS 169925 AND THE EXPIRATION DATE WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE NOTICED THE CUSTOMER WAS MIXING PROCELL DEAD VOLUMES IN ORDER TO RE-USE IT. IT WAS NOTED THE CALIBRATIONS FOR BOTH TPSA AND FPSA WERE EXPIRED. IT WAS NOTED THE CUSTOMER HAD NOT REPLACED THE MEASURING CELL IN THREE YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256011 ELECSYS 2010 IMMUNOCHEMISTRY ANALYZER LTJ ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 059 YR