BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOTAL PSA REAGENT KIT

    MDR report key: 22524028 · Received July 16, 2025

    Report

    Report Number
    3008344661-2025-00098
    Event Type
    Malfunction
    Date Received
    July 16, 2025
    Date of Event
    June 13, 2025
    Report Date
    September 9, 2025
    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

    AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A1 - PATIENT IDENTIFIER COMPLETE ENTRY = (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 7P92-32, 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

    THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND IN-HOUSE TESTING. 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 ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 69274FZ00. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES, OR DEVIATIONS WITH COMPLAINT LOT 69274FZ00. IN-HOUSE TESTING OF A RETAINED REAGENT KIT OF THE COMPLAINT LOT WAS PERFORMED. ALL SPECIFICATIONS WERE MET INDICATING THE LOT IS PERFORMING ACCEPTABLY. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I TOTAL PSA REAGENT LOT 69274FZ00 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I TOTAL PSA RESULT FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2025 SAMPLE ID (B)(6) RESULT = 4.121 NG/ML, NOT REPEATED. THE PATIENT REPORTED A HISTORICAL RESULT A YEAR AGO OF AROUND 0.5-0.6 NG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I TOTAL PSA RESULT FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2025 SAMPLE ID (B)(6) RESULT = 4.121 NG/ML, NOT REPEATED. THE PATIENT REPORTED A HISTORICAL RESULT A YEAR AGO OF AROUND 0.5-0.6 NG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161209 ALINITY I TOTAL PSA REAGENT KIT TOTAL, PROSTATE SPECIFIC AG (NONCOMPLEXED/COMPLEXED) FOR DET OF PROSTATE CANCER MTF ABBOTT IRELAND DIAGNOSTICS DIVISION 69274FZ00 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).