BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOTAL PSA REAGENT KIT

    MDR report key: 22097558 · Received May 28, 2025

    Report

    Report Number
    3008344661-2025-00076
    Event Type
    Malfunction
    Date Received
    May 28, 2025
    Date of Event
    May 13, 2025
    Report Date
    September 3, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MTF
    UDI-DI
    00380740130442
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION OF THE ALINITY I TOTAL PSA REAGENT LOT 72140FZ00 INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, AND DEVICE HISTORY RECORD REVIEW. 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 72140FZ00 WAS NOT IDENTIFIED. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT. 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 72140FZ00 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. COMPLETED INFORMATION FOR SECTION A1 - PATIENT IDENTIFIER: SIDS (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 7P92-30, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P92-21/-31, AND A 510K/PMA/BLA NUMBER P910007.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED ALINITY I TOTAL PSA RESULTS GENERATED FOR PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6) INITIAL RESULT = >1000 NG/ML, 1:15 MANUAL DILUTION RESULT = 520 NG/ML, 1:20 MANUAL DILUTION RESULT = 36 NG/ML. SAMPLE ID (B)(6) 1:15 MANUAL DILUTION RESULT = >1500 NG/ML, 1:20 MANUAL DILUTION RESULT = 72.8 NG/ML. BOTH SAMPLES WERE RETRIEVED AND PROCESSED WITH A 1:20 MANUAL DILUTION GENERATING THE EXPECTED RESULTS WHICH = 1724 NG/ML AND >2000 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DECREASED ALINITY I TOTAL PSA RESULTS GENERATED FOR PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6); INITIAL RESULT = >1000 NG/ML, 1:15 MANUAL DILUTION RESULT = 520 NG/ML, 1:20 MANUAL DILUTION RESULT = 36 NG/ML. SAMPLE ID (B)(6); 1:15 MANUAL DILUTION RESULT = >1500 NG/ML, 1:20 MANUAL DILUTION RESULT = 72.8 NG/ML. BOTH SAMPLES WERE RETRIEVED AND PROCESSED WITH A 1:20 MANUAL DILUTION GENERATING THE EXPECTED RESULTS WHICH = 1724 NG/ML AND >2000 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851131 ALINITY I TOTAL PSA REAGENT KIT TOTAL, PROSTATE SPECIFIC AG (NONCOMPLEXED/COMPLEXED) FOR DET OF PROSTATE CANCER MTF ABBOTT IRELAND DIAGNOSTICS DIVISION 72140FZ00 00380740130442

    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).