BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOTAL PSA REAGENT KIT

    MDR report key: 21876468 · Received April 21, 2025

    Report

    Report Number
    3008344661-2025-00045
    Event Type
    Malfunction
    Date Received
    April 21, 2025
    Date of Event
    April 3, 2025
    Report Date
    June 20, 2025
    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 FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P92 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P92-21 / 31, WITH 510K/PMA/BLA NUMBER P910007.

    Additional Manufacturer Narrative · 0

    INVESTIGATION INTO THE ISSUE HAS IDENTIFIED PERFORMANCE SHIFTS COULD OCCUR WITH SPECIFIC LOTS OF ALINITY I TOTAL PSA REAGENT KIT, LIST NUMBER 07P92, INCLUDING LOT 73155FZ00. A FIELD ACTION HAS BEEN ISSUED AND THE IMPACTED LOTS ARE NOT DISTRIBUTED IN THE US. NO FURTHER INFORMATION WILL BE SUBMITTED. ADDITIONAL INFORMATION IN D10 CONCOMITANT PRODUCT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I TOTAL PSA RESULTS. THE FOLLOWING RESULTS WERE PROVIDED: SPECIMEN (1) (B)(6) 2025 , SID (B)(6), (LOT 73155FZ00) INITIAL RESULT 5.397 NG/ML, REPEATED (LOT 72104FZ00) 3.989 NG/ML, NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I TOTAL PSA RESULTS. THE FOLLOWING RESULTS WERE PROVIDED: SPECIMEN (1) (B)(6) 2025 SID (B)(6) (LOT 73155FZ00) INITIAL RESULT 5.397 NG/ML, REPEATED (LOT 72104FZ00) 3.989 NG/ML, NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1161366 ALINITY I TOTAL PSA REAGENT KIT TOTAL, PROSTATE SPECIFIC AG (NONCOMPLEXED/COMPLEXED) FOR DET OF PROSTATE CANCER MTF ABBOTT IRELAND DIAGNOSTICS DIVISION 73155FZ00 00380740210540

    Patients

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