BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL PSA

    MDR report key: 24446691 · Received February 25, 2026

    Report

    Report Number
    3008344661-2026-00044
    Event Type
    Malfunction
    Date Received
    February 25, 2026
    Date of Event
    February 11, 2026
    Report Date
    March 19, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MTF
    UDI-DI
    00380740112417
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION HAS BEEN INCLUDED. NO ADDITIONAL PATIENT DETAILS ARE AVAILABLE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07K70 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 6C06, WITH 510K NUMBER P910007.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION/CORRECTION: AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ARCHITECT TOTAL PSA, LIST 07K70-35, MANUFACTURING SITE SLIGO, TO THE ARCHITECT I2000SR PROCESSING MODULE, 03M74-01 MANUFACTURING SITE DALLAS. MDR NUMBER 3016438761-2026-00149 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT TOTAL PSA RESULTS FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SID UNKNOWN, INITIAL PSA RESULT WAS 6.18 NG/ML, REPEATED 0.11 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT TOTAL PSA RESULTS FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SID UNKNOWN, INITIAL PSA RESULT WAS 6.18 NG/ML, REPEATED 0.11 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503037 ARCHITECT TOTAL PSA TOTAL, PROSTATE SPECIFIC AG (NONCOMPLEXED/COMPLEXED) FOR DET OF PROSTATE CANCER MTF ABBOTT IRELAND DIAGNOSTICS DIVISION 78463FZ00 00380740112417

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown