BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOTAL PSA REAGENT KIT

    MDR report key: 21978601 · Received May 7, 2025

    Report

    Report Number
    3008344661-2025-00060
    Event Type
    Malfunction
    Date Received
    May 7, 2025
    Date of Event
    April 16, 2025
    Report Date
    August 4, 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 07P92-22 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P92-21 / 31, WITH 510K/PMA/BLA NUMBER P910007.

    Additional Manufacturer Narrative · 0

    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. 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. A REVIEW OF TRACKING AND TRENDING DID IDENTIFY AN INCREASE IN COMPLAINTS FOR LIST NUMBER 07P92, HOWEVER, AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 73155FZ00 WAS NOT IDENTIFIED. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT. IN-HOUSE TESTING OF LOT 73162FZ00, WHICH CONTAINS THE SAME BULK MATERIAL AS LOT 73155FZ00, 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 73155FZ00 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY I TOTAL PSA RESULTS FOR FOUR PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2025. SID (B)(6), INITIAL 4.465 NG/ML, REPEATED 18.264 NG/ML, SID (B)(6), INITIAL 0.739 NG/ML, REPEATED 2.243 NG/ML, SID (B)(6), INITIAL 0.250 NG/ML, REPEATED 1.931 NG/ML, SID (B)(6), INITIAL 4.085 NG/ML, REPEATED 9.010 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY I TOTAL PSA RESULTS FOR FOUR PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025. SID (B)(6) INITIAL 4.465 NG/ML, REPEATED 18.264 NG/ML, SID (B)(6) INITIAL 0.739 NG/ML, REPEATED 2.243 NG/ML, SID (B)(6) INITIAL 0.250 NG/ML, REPEATED 1.931 NG/ML, SID (B)(6) INITIAL 4.085 NG/ML, REPEATED 9.010 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469802 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) | ALNTY I PROCESSING MODU, 03R65-01, (B)(6)