BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALINITY I TOTAL PSA REAGENT KIT

    MDR report key: 23879701 · Received December 23, 2025

    Report

    Report Number
    3008344661-2025-00186
    Event Type
    Injury
    Date Received
    December 23, 2025
    Date of Event
    December 2, 2025
    Report Date
    February 9, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MTF
    UDI-DI
    00380740130435
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P92-20 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P92-21 / 31, 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.

    Additional Manufacturer Narrative · 0

    SECTION B5 - DESCRIBE EVENT OR PROBLEM UPDATED TO INCLUDE ADDITIONAL INFORMATION. THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY I TOTAL PSA RESULTS FOR MULTIPLE PATIENTS. THE CUSTOMER PERFORMED AN INTERNAL INVESTIGATION DUE TO ELEVATED RLU¿S FOR TOTAL PSA CAL1 POTENTIALLY CAUSING THE FALSE DEPRESSED RESULTS. THE CUSTOMER NOTED THAT THE TOTAL PSA ASSAY DOES SHOW SPORADICALLY HIGHER FREQUENCY OF 1044 ERROR CODE AND REQUESTED FURTHER INFORMATION FROM ABBOTT ABOUT THIS. A MEETING WITH THE CUSTOMER WAS HELD ANALYZING THE CUSTOMERS CALIBRATOR 1 RLU, THE FREQUENCY OF ERROR CODE 1044 AND ALSO THE POTENTIAL ROOT CAUSE FOR THE HIGH CALIBRATOR 1 RLU. THE CUSTOMER WAS INFORMED THAT THE INCREASE IN 1044 ERROR CODE WITH ONLY ONE ASSAY CAN BE INDICATIVE OF AN AFFECTED CALIBRATION AND THAT THEY MAY NEED TO CHANGE HANDLING OF THE CALIBRATOR BOTTLES AND USE NEW CALIBRATOR REPLACEMENT CAPS AFTER USE OF THE CALIBRATORS. ABBOTT MANDATES TO USE NEW CALIBRATOR REPLACEMENT CAPS AFTER USE OF THE CALIBRATORS TO PREVENT CARRY-OVER VIA MIXING THE CALIBRATOR CAPS OF CAL 1 AND CAL 2. THIS IS THE MOST PLAUSIBLE ROOT CAUSE FOR THE OBSERVED INCREASE IN CALIBRATOR 1 RLUS. CAL 2 RLU VALUES ARE WITHIN EXPECTED VALUES. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION OF ANY ADDITIONAL ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I TOTAL PSA ASSAY DID NOT IDENTIFY ANY TRENDS RELATED TO THE COMPLAINT ISSUE. A SEARCH FOR SIMILAR COMPLAINTS BY LOT COULD NOT BE CARRIED OUT AS THE LOT NUMBER IS UNKNOWN. AN ASSESSMENT OF ALINITY I TOTAL PSA COMPLAINTS WAS PERFORMED AND CONCLUDED THAT ALL ON MARKET LOTS OF THE ALINITY I TOTAL PSA ASSAY CONTINUE TO PERFORM AS INTENDED. INTERNAL DATA GENERATED BY ABBOTT DID NOT REPLICATE THE CUSTOMERS OBSERVATION. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT ASSAY. FURTHERMORE, LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION THE ALINITY I TOTAL PSA ASSAY IS PERFORMING AS INTENDED, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED. USE ERROR OF INCORRECT CAP HANDLING IS THE MOST PROBABLY CAUSE FOR THE CUSTOMER¿S ISSUE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY I TOTAL PSA FOR MULTIPLE PATIENTS. WHEN THE INITIAL RESULTS WERE COMPARED TO THE RESULTS GENERATED ON THE ROCHE METHODOLOGY, THE RESULTS ON THE ROCHE WERE HIGHER AND ABOVE THE THRESHOLD FOR TREATMENT. THE ONCOLOGISTS WERE USING THRESHOLD DETERMINATION OF 0.100 NG/ML AND 0.2000 NG/ML FOR TREATMENT BASED ON MEDICAL REGULATIONS FROM WEST MIDS CANCER ALLIANCE AND NICE. THE CUSTOMER NOTED THAT A TOTAL OF 26 PATIENTS WERE RETESTED FOR TOTAL PSA AND 2 PATIENTS WERE FOUND TO HAVE A CONFIRMED DELAYED SALVAGE RADIOTHERAPY BASED ON THE INITIAL TOTAL PSA RESULTS. NO ADDITIONAL IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY I TOTAL PSA FOR MULTIPLE PATIENTS. WHEN THE INITIAL RESULTS WERE COMPARED TO THE RESULTS GENERATED ON THE ROCHE METHODOLOGY, THE RESULTS ON THE ROCHE WERE HIGHER AND ABOVE THE THRESHOLD FOR TREATMENT. THE ONCOLOGISTS WERE USING THRESHOLD DETERMINATION OF 0.100 NG/ML AND 0.2000 NG/ML FOR TREATMENT BASED ON MEDICAL REGULATIONS FROM WEST MIDS CANCER ALLIANCE AND NICE. THE CUSTOMER NOTED THAT A TOTAL OF 26 PATIENTS WERE RETESTED FOR TOTAL PSA AND 2 PATIENTS WERE FOUND TO HAVE A CONFIRMED DELAYED SALVAGE RADIOTHERAPY BASED ON THE INITIAL TOTAL PSA RESULTS. UPDATE, CLARIFYING INFORMATION WAS PROVIDED ON 22JAN2026. THE CUSTOMER HAS NOT ANALYZED ANY OF THE PATIENT SAMPLES ON A ROCHE ANALYZER AND THE REVIEW OF TOTAL PSA PATIENT RESULTS WAS BASED ON THE ELEVATED RLUS FOR TOTAL PSA CALIBRATOR LEVEL 1. THE ROCHE AND ABBOTT PSA ASSAYS GIVE DIFFERENT RESULTS ON THE UNITED KINGDOM NATIONAL EXTERNAL QUALITY ASSESSMENT SERVICE (UKNEQAS) AT THE ULTRA-SENSITIVE LEVEL. ON (B)(6), THE CUSTOMER IDENTIFIED TWO ADDITIONAL PATIENTS WITH DELAYED RADIOTHERAPY DURING A LOOK BACK WITH ADDITIONAL CALIBRATION DATA. NO ADDITIONAL IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1829943 ALINITY I TOTAL PSA REAGENT KIT TOTAL, PROSTATE SPECIFIC AG (NONCOMPLEXED/COMPLEXED) FOR DET OF PROSTATE CANCER MTF ABBOTT IRELAND DIAGNOSTICS DIVISION 00380740130435

    Patients

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