BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TOTAL PSA

    MDR report key: 16553757 · Received March 16, 2023

    Report

    Report Number
    1823260-2023-00828
    Event Type
    Malfunction
    Date Received
    March 16, 2023
    Date of Event
    February 17, 2023
    Report Date
    March 16, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MTF
    PMA / PMN Number
    P990056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CALIBRATION WAS LAST PERFORMED ON (B)(6)2022. THE LEVEL 2 QC DATA PROVIDED WAS ACCEPTABLE. THE LEVEL 1 QC RECOVERY DATA WAS NOT PROVIDED. A 5-SAMPLE PRECISION CHECK WAS PERFORMED SUCCESSFULLY. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. DEVICE EVALUATED BY MFR : NA.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TOTAL PSA IMMUNOASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 411 IMMUNOASSAY ANALYZER. THE INITIAL TOTAL PSA RESULT WAS 39.22 NG/ML WITH FLAG. THE SAMPLE WAS RE-CENTRIFUGED, POURED INTO AN ALIQUOT CUP, AND REPEATED. THE REPEAT RESULT WAS 1.52 NG/ML. THE SAMPLE WAS REPEATED A SECOND TIME AND GAVE THE SAME RESULT AS THE FIRST RERUN. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE ANALYZER SERIAL NUMBER WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495693 ELECSYS TOTAL PSA TOTAL PROSTATE SPECIFIC ANTIGEN MTF ROCHE DIAGNOSTICS NA 6489730

    Patients

    Seq Age Sex Outcome Treatment
    1 Male