BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOTAL PSA REAGENT KIT

    MDR report key: 22053512 · Received May 20, 2025

    Report

    Report Number
    3008344661-2025-00070
    Event Type
    Malfunction
    Date Received
    May 20, 2025
    Date of Event
    March 14, 2025
    Report Date
    June 6, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MTF
    UDI-DI
    00380740130435
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 07P92-20 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.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I TOTAL PSA RESULTS WHEN USING A NEW REAGENT LOT, 73155FZ00, COMPARED TO ANOTHER REAGENT LOT, 72104FZ00. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER PROVIDED REFERENCE RANGE: <4.00 NG/ML): RESULT USING REAGENT LOT 73155FZ00= 5.95 NG/ML RESULT USING REAGENT LOT 72104FZ00 = 2.95 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I TOTAL PSA RESULTS WHEN USING A NEW REAGENT LOT, 73155FZ00, COMPARED TO ANOTHER REAGENT LOT, 72104FZ00. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER PROVIDED REFERENCE RANGE: <4.00 NG/ML): RESULT USING REAGENT LOT 73155FZ00= 5.95 NG/ML RESULT USING REAGENT LOT 72104FZ00 = 2.95 NG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2356226 ALINITY I TOTAL PSA REAGENT KIT TOTAL, PROSTATE SPECIFIC AG (NONCOMPLEXED/COMPLEXED) FOR DET OF PROSTATE CANCER MTF ABBOTT IRELAND DIAGNOSTICS DIVISION 73155FZ00 00380740130435

    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)