BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL PSA

    MDR report key: 23366650 · Received October 23, 2025

    Report

    Report Number
    3008344661-2025-00146
    Event Type
    Malfunction
    Date Received
    October 23, 2025
    Date of Event
    October 14, 2025
    Report Date
    December 10, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MTF
    UDI-DI
    00380740159849
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORTED THE COMPLAINT ISSUE WITHOUT INDICATION OF ANY ADDITIONAL ISSUES. A SEARCH FOR SIMILAR COMPLAINTS DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 73579FZ01. A REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT TOTAL PSA ASSAY DID NOT IDENTIFY ANY TRENDS RELATED TO THE COMPLAINT ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES OR DEVIATIONS WITH LOT NUMBER 73579FZ01AND THE COMPLAINT ISSUE. IN-HOUSE PERFORMANCE TESTING WAS PERFORMED UTILIZING RETAINED REAGENT KIT OF THE COMPLAINT LOT. ALL TESTING PASSED INDICATING THE REAGENT LOT IS PERFORMING AS EXPECTED. A REVIEW OF LABELING WAS PERFORMED AND FOUND TO SUFFICIENTLY ADDRESS THE CUSTOMER¿S ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ARCHITECT TOTAL PSA REAGENT, LOT NUMBER73579FZ01.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07K70-74 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 6C06, WITH PMA NUMBER P910007. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT TOTAL PSA RESULTS FOR ONE PATIENT. THE RESULTS WERE NOT REPORTED OUT OF THE LAB. THE TOTAL PSA UNIT IS NG/ML, WITH A REFERENCE RANGE OF 0-4 NG/ML. THE SPECIFIC DATA ARE AS FOLLOWS: SID 2 INITIAL RESULT 0.002 NG/ML, REPEATED 6.087 NG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT TOTAL PSA RESULTS FOR ONE PATIENT. THE RESULTS WERE NOT REPORTED OUT OF THE LAB. THE TOTAL PSA UNIT IS NG/ML, WITH A REFERENCE RANGE OF 0-4 NG/ML. THE SPECIFIC DATA ARE AS FOLLOWS: SID 2 INITIAL RESULT 0.002 NG/ML, REPEATED 6.087 NG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1931242 ARCHITECT TOTAL PSA TOTAL, PROSTATE SPECIFIC AG (NONCOMPLEXED/COMPLEXED) FOR DET OF PROSTATE CANCER MTF ABBOTT IRELAND DIAGNOSTICS DIVISION 73579FZ01 00380740159849

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC I2000SR INST, 03M74-02, (B)(6)