BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOTAL PSA REAGENT KIT

    MDR report key: 21680099 · Received March 24, 2025

    Report

    Report Number
    3008344661-2025-00035
    Event Type
    Malfunction
    Date Received
    March 24, 2025
    Date of Event
    December 2, 2024
    Report Date
    June 12, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MTF
    UDI-DI
    00380740130442
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. A1 - PATIENT IDENTIFIER: (B)(6) (COMPLETE ID AS IT EXCEEDED THE ALLOWABLE CHARACTERS FOR THIS FIELD.) ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P92-30 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07P92-21/-31, 510K/PMA/BLA 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. 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 FOR THE ALINITY I TOTAL PSA ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 70089FZ00. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT AND COMPLAINT ISSUE. ACCURACY TESTING WAS PERFORMED USING A RETAINED KIT OF THE COMPLAINT LOT. ALL SPECIFICATIONS WERE MET INDICATING THE LOT IS PERFORMING ACCEPTABLY. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY OF THE ALINITY I TOTAL PSA REAGENT LOT 70089FZ00 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I TOTAL PSA RESULT GENERATED ON THE ALINITY I PROCESSING MODULE FOR ONE PATIENT USING REAGENT LOT 70089FZ00. THE FOLLOWING DATA WAS PROVIDED (NORMAL RANGE: </= 4.0 NG/ML): SID (B)(6) TESTED ON (B)(6)2024 (REAGENT LOT USED 70089FZ00). TOTAL PSA RESULT = 9.64 NG/ML (RESULT REPORTED OUT TO THE DOCTOR). PATIENT AND DOCTOR QUESTIONED THE RESULT AND ASKED TO HAVE IT RETESTED. A NEW SAMPLE WAS DRAWN AND RETESTED FOR TOTAL PSA ON 15JAN2025 AND GENERATED A RESULT OF 0.16 NG/ML (ACCORDING TO THE DOCTOR THIS RESULT CORRELATED TO THE PATIENT¿S MEDICAL CONDITION). PREVIOUS RESULT = 0.4 NG/ML. ALL LEVELS OF QC WERE WITHIN RANGE USING REAGENT LOT 70089FZ00: LEVEL 1: 0.67 (TARGET MEAN: 0.662, RANGE: 0.463-0.861). LEVEL 2: 4.1 (TARGET MEAN: 4.03, RANGE:3.22-4.83). LEVEL 3: 24.62 (TARGET MEAN: 22.5, RANGE: 18.0-27.1) . THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I TOTAL PSA RESULT GENERATED ON THE ALINITY I PROCESSING MODULE FOR ONE PATIENT USING REAGENT LOT 70089FZ00. THE FOLLOWING DATA WAS PROVIDED (NORMAL RANGE: </= 4.0 NG/ML): SID (B)(6) TESTED ON (B)(6) 2024 (REAGENT LOT USED 70089FZ00). TOTAL PSA RESULT = 9.64 NG/ML (RESULT REPORTED OUT TO THE DOCTOR). PATIENT AND DOCTOR QUESTIONED THE RESULT AND ASKED TO HAVE IT RETESTED. A NEW SAMPLE WAS DRAWN AND RETESTED FOR TOTAL PSA ON (B)(6) 2025 AND GENERATED A RESULT OF 0.16 NG/ML (ACCORDING TO THE DOCTOR THIS RESULT CORRELATED TO THE PATIENT¿S MEDICAL CONDITION) PREVIOUS RESULT = 0.4 NG/ML. ALL LEVELS OF QC WERE WITHIN RANGE USING REAGENT LOT 70089FZ00: LEVEL 1: 0.67 (TARGET MEAN: 0.662, RANGE: 0.463-0.861), LEVEL 2: 4.1 (TARGET MEAN: 4.03, RANGE:3.22-4.83), LEVEL 3: 24.62 (TARGET MEAN: 22.5, RANGE: 18.0-27.1) . THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482463 ALINITY I TOTAL PSA REAGENT KIT TOTAL, PROSTATE SPECIFIC AG (NONCOMPLEXED/COMPLEXED) FOR DET OF PROSTATE CANCER MTF ABBOTT IRELAND DIAGNOSTICS DIVISION 70089FZ00 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)