BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOTAL PSA REAGENT KIT

    MDR report key: 23587353 · Received November 18, 2025

    Report

    Report Number
    3008344661-2025-00161
    Event Type
    Malfunction
    Date Received
    November 18, 2025
    Date of Event
    November 5, 2025
    Report Date
    February 11, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MTF
    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 FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. COMPLETED INFORMATION FOR SECTION A1 - PATIENT IDENTIFIER: (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P92-22, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P92-21/-31, AND A 510K/PMA/BLA NUMBER P910007.

    Additional Manufacturer Narrative · 0

    DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I TOTAL PSA REAGENT DID NOT IDENTIFY ANY TRENDS RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, NO TRENDS WERE IDENTIFIED FOR LOT 76586FZ00. THE DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT ISSUE. IN-HOUSE TESTING WAS PERFORMED USING A RETAINED KIT OF REAGENT LOT 76586FZ00. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE.. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY OF THE ALINITY I TOTAL PSA REAGENT LOT 76586FZ00 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY DECREASED ALINITY I TOTAL PSA RESULT GENERATED FOR AN 84-YEAR-OLD MALE PATIENT SAMPLE. THE PATIENT HAS A HISTORY OF PROSTATE CANCER AND IS UNDERGOING HORMONE THERAPY. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 0-4 NG/ML): SAMPLE ID (B)(6) SERUM INITIAL RESULT = 1.445 NG/ML, SAMPLE ID (B)(6) AUTOMATIC 10-FOLD DILUTION RESULT = 1.790 NG/ML, SAMPLE ID (B)(6) RECENTRIFUGED SERUM RESULT = 1.584 NG/ML, SAMPLE ID (B)(6) PLASMA RESULT = 1.705 NG/ML. PREVIOUS RESULTS: SEPTEMBER RESULT = 51.7 NG/ML. OCTOBER RESULT = 60.5 NG/ML. REPRODUCIBILITY RESULTS WERE CONSISTENT WITH THE MEASURED VALUES OBTAINED AT THE CUSTOMER'S FACILITY. DILUTION RESULTS SHOWED NO INCREASE IN MEASUREMENT VALUES. NO DECREASE IN THE MEASURED VALUES WAS OBSERVED AFTER THE ADDITION OF THE HETEROPHILIC ANTIBODY BLOCKER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY DECREASED ALINITY I TOTAL PSA RESULT GENERATED FOR AN 84-YEAR-OLD MALE PATIENT SAMPLE. THE PATIENT HAS A HISTORY OF PROSTATE CANCER AND IS UNDERGOING HORMONE THERAPY. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 0-4 NG/ML): SAMPLE ID (B)(6) SERUM INITIAL RESULT = 1.445 NG/ML, SAMPLE ID 477 AUTOMATIC 10-FOLD DILUTION RESULT = 1.790 NG/ML, SAMPLE ID (B)(6) RECENTRIFUGED SERUM RESULT = 1.584 NG/ML, SAMPLE ID (B)(6) PLASMA RESULT = 1.705 NG/ML. PREVIOUS RESULTS: SEPTEMBER RESULT = 51.7 NG/ML OCTOBER RESULT = 60.5 NG/ML REPRODUCIBILITY RESULTS WERE CONSISTENT WITH THE MEASURED VALUES OBTAINED AT THE CUSTOMER'S FACILITY. DILUTION RESULTS SHOWED NO INCREASE IN MEASUREMENT VALUES. NO DECREASE IN THE MEASURED VALUES WAS OBSERVED AFTER THE ADDITION OF THE HETEROPHILIC ANTIBODY BLOCKER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1643539 ALINITY I TOTAL PSA REAGENT KIT TOTAL, PROSTATE SPECIFIC AG (NONCOMPLEXED/COMPLEXED) FOR DET OF PROSTATE CANCER MTF ABBOTT IRELAND DIAGNOSTICS DIVISION 76586FZ00

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male ALNTY I PROCESSING MODU, 03R65-01, (B)(6).