BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOTAL PSA REAGENT KIT

    MDR report key: 23815838 · Received December 16, 2025

    Report

    Report Number
    3008344661-2025-00182
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Date of Event
    November 26, 2025
    Report Date
    February 18, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MTF
    UDI-DI
    00380740210540
    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. 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. A REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I TOTAL PSA ASSAY WAS NOT ABLE TO BE PERFORMED AS THE COMPLAINT LOT NUMBER WAS UNKNOWN. A SEARCH FOR SIMILAR COMPLAINTS BY LOT COULD NOT BE CARRIED OUT AS THE LOT NUMBER IS UNKNOWN. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY OF THE ALINITY I TOTAL PSA REAGENT WITH UNKNOWN LOT WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY DECREASED ALINITY I TOTAL PSA RESULT GENERATED FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE <4.0 NG/ML): INITIAL RESULT ON ALIQUOTED SAMPLE = 0.001 NG/ML, REPEAT RESULT WITH PARENT SAMPLE = 4.104 NG/ML THE CUSTOMER BELIEVES THE 4.104 NG/ML IS CORRECT. 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 A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE <4.0 NG/ML): INITIAL RESULT ON ALIQUOTED SAMPLE = 0.001 NG/ML, REPEAT RESULT WITH PARENT SAMPLE = 4.104 NG/ML THE CUSTOMER BELIEVES THE 4.104 NG/ML IS CORRECT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3497 ALINITY I TOTAL PSA REAGENT KIT TOTAL, PROSTATE SPECIFIC AG (NONCOMPLEXED/COMPLEXED) FOR DET OF PROSTATE CANCER MTF ABBOTT IRELAND DIAGNOSTICS DIVISION 00380740210540

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY I PROCESSING MODU, 03R65-01, (B)(6). | ALNTY I PROCESSING MODU, 03R65-01, (B)(6).