BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 2875253 · Received December 17, 2012

    Report

    Report Number
    1823260-2012-06346
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Date of Event
    November 22, 2012
    Report Date
    February 15, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LTJ
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S RESULT WAS CONFIRMED DURING INVESTIGATION OF THIS EVENT. GEL FILTRATION OF THE PATIENT SAMPLES WAS PERFORMED AND THE RESULT WAS THE SAME. THE ROOT CAUSE COULD NOT BE DETERMINED FOR DISCREPANT RESULTS FOR ONE PATIENT WHEN DIFFERENT METHODS ARE COMPARED. THE DIFFERENCE BETWEEN METHODS IS ADDRESSED IN THE PACKAGE INSERT.

    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 A QUESTIONABLE TOTAL PROSTATE- SPECIFIC ANTIGEN (TPSA) RESULT ON THEIR E-MODULE. THE PATIENT'S INITIAL TPSA RESULT WAS 103 NG/ML. THE SAMPLE WAS THEN TESTED ON AN ARCHITECT ANALYZER AND THE RESULT WAS 175 NG/ML. IT WAS UNKNOWN IF EITHER RESULT WAS REPORTED OUTSIDE THE LABORATORY. THERE WERE NO ADVERSE EVENTS. THE TPSA REAGENT LOT NUMBER AND EXPIRATION DATE WERE NO 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