BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOTAL PSA REAGENT KIT

    MDR report key: 20951189 · Received December 17, 2024

    Report

    Report Number
    3008344661-2024-00155
    Event Type
    Malfunction
    Date Received
    December 17, 2024
    Date of Event
    October 29, 2024
    Report Date
    February 12, 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
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF COMPLAINTS FOR THE ALINITY I TOTAL PSA, LOT# 70093FZ00 ASSAY DETERMINED THAT THERE ARE NO TRENDS FOR THE PRODUCT RELATED TO PATIENT RESULTS. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A RETAINED KIT OF REAGENT LOT 70093FZ00 WAS TESTED FOR ACCURACY AND THE DATA SHOWS THAT THE PERFORMANCE OF THE LOT IS PERFORMING ACCEPTABLY. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ALINITY I TOTAL PSA, LOT# 70093FZ00 ASSAY.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P92-20 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P92-21, WITH 510K/PMA/BLA NUMBER P910007.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I TOTAL PSA ON A MALE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2024 SID (B)(6) = 7.773 NG/ML, ANOTHER LABORATORY = 1.0 NG/ML. (B)(6) 2024 SID (B)(6) = 1.059 NG/ML, FREE PSA = 0.564; SAMPLE REPEATED ON OTHER ALINITY ANALYZERS ON (B)(6) 2024 = 1.1270 / 1.0780 / 1.2040 NG/ML. REFERENCE RANGE: < 4.0 NG/ML . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I TOTAL PSA ON A MALE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2024 , SID (B)(6) = 7.773 NG/ML, ANOTHER LABORATORY = 1.0 NG/ML. (B)(6) 2024 , SID (B)(6) = 1.059 NG/ML, FREE PSA = 0.564; SAMPLE REPEATED ON OTHER ALINITY ANALYZERS ON (B)(6) 2024 = 1.1270 / 1.0780 / 1.2040 NG/ML. REFERENCE RANGE: < 4.0 NG/ML . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292501 ALINITY I TOTAL PSA REAGENT KIT TOTAL, PROSTATE SPECIFIC AG (NONCOMPLEXED/COMPLEXED) FOR DET OF PROSTATE CANCER MTF ABBOTT IRELAND DIAGNOSTICS DIVISION 70093FZ00 00380740130435

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male ALNTY I PROCESSING MODU, 03R65-01, AI01653| ALNTY I PROCESSING MODU, 03R65-01, AI01653