BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TOTAL PSA IMMUNOASSAY

    MDR report key: 8085288 · Received November 19, 2018

    Report

    Report Number
    1823260-2018-04378
    Event Type
    Malfunction
    Date Received
    November 19, 2018
    Date of Event
    October 18, 2018
    Report Date
    January 4, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MTF
    PMA / PMN Number
    P990056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A DECREASE IN CALIBRATION SIGNALS WAS NOTED WITH THE CUSTOMER¿S DATA. QC RECOVERY WAS WITHIN THE SPECIFIED RANGE. THE ALARM TRACE SHOWED A PRE CLEAN SHORT ALARM. A GENERAL PRODUCT PROBLEM WAS EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE HIGH ELECSYS TOTAL PSA IMMUNOASSAY RESULT FOR ONE PATIENT SAMPLE FROM COBAS E 801 MODULE 1617-07. THE RESULT DID NOT FIT WITH THE CLINICAL PICTURE FOR THE PATIENT. THE PATIENT WAS BEING TREATED FOR PROSTATE CANCER AND THE PREVIOUS TOTAL PSA RESULTS HAD BEEN LOW. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. ON (B)(6) 2018, THE TOTAL PSA RESULT WAS 2.7 NG/ML. A FEW DAYS LATER, A NEW SAMPLE WAS DRAWN FROM THE PATIENT AND THE TOTAL PSA RESULT WAS 0.27 NG/ML. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926403 ELECSYS TOTAL PSA IMMUNOASSAY TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) MTF ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1