BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOTAL PSA REAGENT KIT

    MDR report key: 21350079 · Received February 10, 2025

    Report

    Report Number
    3008344661-2025-00013
    Event Type
    Malfunction
    Date Received
    February 10, 2025
    Date of Event
    January 17, 2025
    Report Date
    May 1, 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
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1 PATIENT IDENTIFIER: COMPLETE LIST OF SAMPLE ID'S ARE (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P92-20 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07P92-21/31, WITH 510K/PMA/BLA NUMBER P910007. 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 OF A RETAINED REAGENT KIT LOT 69271FZ00. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. THE TICKET SEARCH BY LOT INDICATES THAT THE REAGENT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. THE TICKET TRENDING REVIEW DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT. IN-HOUSE TESTING WAS COMPLETED USING PANELS WHICH MIMIC PATIENT SAMPLES USING AN IN-HOUSE RETAINED KIT. ALL SPECIFICATIONS WERE MET INDICATING THE LOT IS PERFORMING ACCEPTABLY. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I TOTAL PSA REAGENT LOT 69271FZ00 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED ALINITY I TOTAL PSA AND PROVIDED THE FOLLOWING DATA FOR A MALE PATIENT WITH A HISTORY OF PROSTATIC HYPERPLASIA, PRESENTING WITH URINARY TRACT INFECTION AND HEMATURIA. SAMPLE ID (B)(6) WAS DRAWN ON (B)(6) 2025: ON THE BECKMAN PLATFORM THE TOTAL PSA WAS 57.997. THE SAMPLE WAS REPEATED ON THE ALINITY PLATFORM ON (B)(6) 2025 THE TOTAL PSA WAS 0.193 A SECOND SAMPLE (SAMPLE ID (B)(6) WAS DRAWN ON (B)(6) 2025: ON THE BECKMAN PLATFORM THE TOTAL PSA WAS 25.228. THE SAMPLE WAS REPEATED ON THE ALINITY PLATFORM ON (B)(6) 2025 THE TOTAL PSA WAS 23.635. PATIENT HISTORICAL VALUES: ON (B)(6) 2024, THE TOTAL PSA WAS 13.377 (PLATFORM UNKNOWN). PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED ALINITY I TOTAL PSA AND PROVIDED THE FOLLOWING DATA FOR A MALE PATIENT WITH A HISTORY OF PROSTATIC HYPERPLASIA, PRESENTING WITH URINARY TRACT INFECTION AND HEMATURIA. SAMPLE ID (B)(6) WAS DRAWN ON 10 JAN 2025: ON THE BECKMAN PLATFORM THE TOTAL PSA WAS 57.997. THE SAMPLE WAS REPEATED ON THE ALINITY PLATFORM ON (B)(6) 2025 THE TOTAL PSA WAS 0.193 A SECOND SAMPLE (SAMPLE ID (B)(6)) WAS DRAWN ON 13 JAN 2025: ON THE BECKMAN PLATFORM THE TOTAL PSA WAS 25.228. THE SAMPLE WAS REPEATED ON THE ALINITY PLATFORM ON (B)(6) 2025 THE TOTAL PSA WAS 23.635. PATIENT HISTORICAL VALUES: ON (B)(6) 2024, THE TOTAL PSA WAS 13.377 (PLATFORM UNKNOWN). PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960234 ALINITY I TOTAL PSA REAGENT KIT TOTAL, PROSTATE SPECIFIC AG (NONCOMPLEXED/COMPLEXED) FOR DET OF PROSTATE CANCER MTF ABBOTT IRELAND DIAGNOSTICS DIVISION 69271FZ00 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)