BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOTAL PSA REAGENT KIT

    MDR report key: 24203317 · Received January 28, 2026

    Report

    Report Number
    3008344661-2026-00017
    Event Type
    Malfunction
    Date Received
    January 28, 2026
    Date of Event
    December 2, 2025
    Report Date
    March 6, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MTF
    UDI-DI
    00380740210557
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR A FALSELY ELEVATED ALINITY I TOTAL PSA RESULT INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, TRENDING DATA, LABELING, DEVICE HISTORY RECORDS, AND TESTING OF RETAINED REAGENT KITS OF THE COMPLAINT LOT NUMBER. TRENDING REVIEW DETERMINED NO RELATED TREND FOR THE ISSUE FOR THE PRODUCT. ACCURACY TESTING WAS PERFORMED USING PANELS, WHICH MIMICS PATIENT SAMPLES, AND AN IN-HOUSE RETAINED KIT OF LOT 77473FZ00 STORED AT THE RECOMMENDED STORAGE CONDITION. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE LOT AND COMPLAINT ISSUE. MANUFACTURING DOCUMENTATION FOR THE LOT WAS REVIEWED AND DID NOT IDENTIFY ANY ISSUES. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I TOTAL PSA ASSAY, LOT NUMBER 77473FZ00, WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. A1 PATIENT IDENTIFIER: COMPLETE SAMPLE ID= (B)(6) ARE FROM THE SAME PATIENT. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED; NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P92-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P92-21 / 31, WITH 510K/PMA/BLA NUMBER P910007.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I TOTAL PSA RESULT ON A PATIENT. RESULT WAS NOT REPORTED TO MEDICAL PROVIDER. THE FOLLOWING DATA WAS PROVIDED. (B)(6) 2025, SID (B)(6), INITIAL RESULT = 4.628 NG/ML. REPEAT RESULTS = 0.006 NG/ML & 0.005 NG/ML (SID (B)(6)). HISTORICAL RESULT WAS ALSO BELOW LOWER LIMIT (NO SPECIFIC DATA PROVIDED). SID (B)(6) ARE FROM THE SAME PATIENT. REFERENCE RANGE: </= 4 NG/ML. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I TOTAL PSA RESULT ON A PATIENT. RESULT WAS NOT REPORTED TO MEDICAL PROVIDER. THE FOLLOWING DATA WAS PROVIDED. ON (B)(6) 2025, SID (B)(6), INITIAL RESULT = 4.628 NG/ML. REPEAT RESULTS = 0.006 NG/ML & 0.005 NG/ML (SID(B)(6). HISTORICAL RESULT WAS ALSO BELOW LOWER LIMIT (NO SPECIFIC DATA PROVIDED). SID (B)(6) ARE FROM THE SAME PATIENT. REFERENCE RANGE: </= 4 NG/ML. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266322 ALINITY I TOTAL PSA REAGENT KIT TOTAL, PROSTATE SPECIFIC AG (NONCOMPLEXED/COMPLEXED) FOR DET OF PROSTATE CANCER MTF ABBOTT IRELAND DIAGNOSTICS DIVISION 77473FZ00 00380740210557

    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)