BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOTAL PSA REAGENT KIT

    MDR report key: 22503617 · Received July 14, 2025

    Report

    Report Number
    3008344661-2025-00097
    Event Type
    Malfunction
    Date Received
    July 14, 2025
    Date of Event
    May 14, 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 FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. A1 PATIENT IDENTIFIER: COMPLETE SAMPLE ID IS (B)(6) 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.

    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 DATA FOR THE ALINITY I TOTAL PSA ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINTS. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR THE REAGENT LOT. DEVICE HISTORY REVIEW DID NOT IDENTIFY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. TESTING WAS PERFORMED USING AN IN-HOUSE RETAIN KIT OF LOT 69274FZ00. ALL SPECIFICATIONS WERE MET INDICATING THE LOT IS PERFORMING ACCEPTABLY. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I TOTAL PSA REAGENT WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED ELEVATED ALINITY I TOTAL PSA. THE PATIENT¿S DOCTOR QUESTIONED WHY THE RESULT WAS HIGHER THAN THE PREVIOUS VALUE. THE CUSTOMER PROVIDED THE FOLLOWING DATA: ON (B)(6) 2025, SAMPLE ID (B)(6) TOTAL PSA RESULT WAS 5.613 NG/ML. LAST YEAR THE PATIENT¿S RESULT WAS APPROXIMATELY 0.5 TO 0.6. NG/ML. NO RETEST WAS PERFORMED, AND NO PATIENT DATA WAS PROVIDED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED ELEVATED ALINITY I TOTAL PSA. THE PATIENT¿S DOCTOR QUESTIONED WHY THE RESULT WAS HIGHER THAN THE PREVIOUS VALUE. THE CUSTOMER PROVIDED THE FOLLOWING DATA: ON (B)(6) 2025, SAMPLE ID (B)(6) TOTAL PSA RESULT WAS 5.613 NG/ML. LAST YEAR THE PATIENT¿S RESULT WAS APPROXIMATELY 0.5 TO 0.6. NG/ML. NO RETEST WAS PERFORMED, AND NO PATIENT DATA WAS PROVIDED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1771446 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).