BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOTAL PSA REAGENT KIT

    MDR report key: 22126522 · Received June 2, 2025

    Report

    Report Number
    3008344661-2025-00080
    Event Type
    Malfunction
    Date Received
    June 2, 2025
    Date of Event
    December 19, 2024
    Report Date
    August 28, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MTF
    UDI-DI
    00380740130435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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. 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 07P92-20, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07P92-21, AND A PMA NUMBER OF P910007.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSELY DECREASED ALINITY I TOTAL PSA RESULTS INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, TRENDING DATA, LABELING, AND DEVICE HISTORY RECORDS. THE CUSTOMER OBSERVED RESULTS BELOW THE MEASURING INTERVAL OF THE ALINITY I TOTAL PSA ASSAY WHEN USING ALINITY I TOTAL PSA REAGENT KIT, LOT NUMBER 71210FZ00. IT WAS NOTED THAT THE LOWER LIMIT OF LINEARITY WAS SET TO 0.00 UG/L INSTEAD OF 0.025 UG/L (LOWER LIMIT OF THE MEASURING INTERVAL). THE PARAMETER IS AN EDITABLE PARAMETER AND HAS BEEN UPDATED, AND CUSTOMER HAS CONFIRMED THE CORRECT RESULTS ARE NOW SHOWING. A REVIEW OF TRACKING AND TRENDING FOR THE PRODUCT AND THE LIKELY CAUSE LOT DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE LIKELY CAUSE LOT AND COMPLAINT ISSUE. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LOT WAS REVIEWED AND DID NOT IDENTIFY ANY ISSUES. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE INFORMATION PROVIDED AND ABBOTT DIAGNOSTICS¿ COMPLAINT INVESTIGATION, ALINITY I TOTAL PSA ASSAY, LOT NUMBER 71210FZ00, IS PERFORMING AS INTENDED AND NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED ALINITY I TOTAL PSA RESULTS FOR NUMEROUS PATIENTS. THE FOLLOWING EXAMPLE WAS PROVIDED: SAMPLE ID (B)(6) RESULT WAS 0.00 UG/L THE CUSTOMER STATED THE ASSAY FILE WAS CONFIGURED INCORRECTLY WITH THE LOWER LIMIT OF LINEARITY AT 0.00 WHERE IT IS SUPPOSED TO BE 0.03 UG/L. THE ASSAY FILES WERE UNINSTALLED AND RECONFIGURED ON 19DEC2024 AS A PART OF A SERVICE VISIT WITH THE CUSTOMER. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED ALINITY I TOTAL PSA RESULTS FOR NUMEROUS PATIENTS. THE FOLLOWING EXAMPLE WAS PROVIDED: SAMPLE ID (B)(6) RESULT WAS 0.00 UG/L. THE CUSTOMER STATED THE ASSAY FILE WAS CONFIGURED INCORRECTLY WITH THE LOWER LIMIT OF LINEARITY AT 0.00 WHERE IT IS SUPPOSED TO BE 0.03 UG/L. THE ASSAY FILES WERE UNINSTALLED AND RECONFIGURED ON (B)(6) 2024 AS A PART OF A SERVICE VISIT WITH THE CUSTOMER. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1461496 ALINITY I TOTAL PSA REAGENT KIT TOTAL, PROSTATE SPECIFIC AG (NONCOMPLEXED/COMPLEXED) FOR DET OF PROSTATE CANCER MTF ABBOTT IRELAND DIAGNOSTICS DIVISION 71210FZ00 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)