BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 2477866 · Received March 5, 2012

    Report

    Report Number
    1823260-2012-01229
    Event Type
    Malfunction
    Date Received
    March 5, 2012
    Date of Event
    February 10, 2012
    Report Date
    May 30, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LTJ
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE. THE PROVIDED CALIBRATION, QUALITY CONTROL AND PERFORMANCE TESTING DATA DID NOT INDICATE ANY REAGENT OR SYSTEM ISSUE. THE RESULTS WERE NOT REPRODUCIBLE. THE PATIENT WAS NOT HARMED BY ANY ACTION TAKEN.

    Additional Manufacturer Narrative · 1

    THE TOTAL PSA REAGENT LOT NUMBER WAS 163492. THE FREE PSA REAGENT LOT NUMBER WAS 165433.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE TOTAL PSA (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TOTAL PSA) AND FREE PSA RESULTS FOR ONE SAMPLE FROM A PATIENT BORN IN (B)(6). THE INITIAL RESULTS FROM A SAMPLE IN A CUP PROCESSED BY THE MODULAR PREANALYTIC SYSTEM (MPA) WERE A TOTAL PSA OF 7.29 NG/ML AND A FREE PSA OF 4.54 NG/ML. THESE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. ON (B)(6) 2012, THE SAME SAMPLE WAS RETESTED AND THE TOTAL PSA RESULT WAS 1.2 NG/ML AND THE FREE PSA RESULT WAS 0.24 NG/ML. ON (B)(6) 2012, A NEW SAMPLE FROM THE SAME PATIENT WAS TESTED AND THE TOTAL PSA RESULT WAS 1.08 NG/ML AND THE FREE PSA RESULT WAS 0.213 NG/ML. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE TOTAL PSA AND FREE PSA REAGENT LOT NUMBERS AND EXPIRATION DATES WERE NOT PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 064 YR