BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 2971632 · Received February 21, 2013

    Report

    Report Number
    1823260-2013-01102
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 21, 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

    THIS EVENT OCCURED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED A QUESTIONABLE TOTAL PROSTATE- SPECIFIC ANTIGEN (TPSA) RESULT ON THEIR E-MODULE. THE PATIENT'S INITIAL TPSA RESULT WAS 0.017 NG/ML. THE PATIENT'S INITIAL FREE PROSTATE-SPECIFIC ANTIGEN (FPSA) RESULT WAS 0.075 NG/ML. THESE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE INITIAL RESULTS WERE QUESTIONED AND RETESTED. ON (B)(6) 2013, THE SAMPLE WAS REPEATED ON ANOTHER E-MODULE, SERIAL NUMBER (B)(4). THE TPSA RESULT WAS 0.344 NG/ML AND THE FPSA RESULT WAS 0.088 NG/ML. ON (B)(6) 2013, THE SAMPLE WAS REPEATED ON ANOTHER E-MODULE, SERIAL NUMBER NOT PROVIDED. THE TPSA RESULT WAS 0.358 NG/ML AND THE FPSA RESULT WAS 0.077 NG/ML. AFTER ALL THE ANALYSIS, THE FINAL REPORTED RESULTS WERE TPSA OF 0.344 NG/ML AND FPSA OF 0.075 NG/ML. THERE WERE NO REPORTS OF ANY ADVERSE EVENTS. THE TPSA REAGENT LOT NUMBER WAS 169925 AND THE EXPIRATION DATE WAS NOT PROVIDED. A PERFORMANCE TEST WAS DONE AND EVERYTHING WAS WITHIN RANGE. IT WAS RECOMMENDED THE CUSTOMER PERFORM A LIQUID FLOW CLEANING. THE CALIBRATION AND QUALITY CONTROL WERE WITHIN RANGE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76575 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER LTJ ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 043 YR