BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALINITY I TOTAL PSA REAGENT KIT

    MDR report key: 14621830 · Received June 7, 2022

    Report

    Report Number
    3008344661-2022-00059
    Event Type
    Injury
    Date Received
    June 7, 2022
    Date of Event
    June 3, 2021
    Report Date
    June 20, 2022
    Manufacturer
    ABBOTT IRELAND
    Product Code
    MTF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 7P92-20 / 30 HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P92-21 / 31.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ALINITY I TOTAL PSA, LIST NUMBER 07P92-20, ABBOTT IRELAND, SLIGO, IRELAND TO ALINITY I TOTAL PSA, LIST NUMBER 07P92-30, ABBOTT IRELAND, SLIGO, IRELAND. MDR NUMBER 3008344661-2022-00067-00 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I TOTAL PSA RESULTS FOR ONE PATIENT WHO WAS DIAGNOSED WITH PROSTATE CANCER. IT IS UNKNOWN WHAT OTHER DIAGNOSTIC PROCEDURES WERE PERFORMED BEFORE THE PROSTATE RESECTION. THE FOLLOWING INFORMATION WAS PROVIDED: EARLY IN 2021 TOTAL PSA RESULT = 7.96 NG/ML AND THE PATIENT UNDERWENT PROSTATE RESECTION. (B)(6) 2021 AND (B)(6) 2021 TOTAL PSA RESULT AFTER SURGERY = 0.22 NG/ML. 08NOV2021 PATIENT UNDERWENT ANOTHER SURGERY DUE TO TOTAL PSA RESULT = 0.26 NG/ML. THE PHYSICIAN IS USING PSA GUIDELINES OF TOTAL PSA > 0.20 NG/ML IS CONSIDERED RECURRENCE. 09MAR2022 TOTAL PSA RESULT = 0.15 NG/ML. 02MAY2022 TOTAL PSA RESULT = 0.20 NG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578966 ALINITY I TOTAL PSA REAGENT KIT TOTAL, PROSTATE SPECIFIC AG (NONCOMPLEXED/COMPLEXED) FOR DET OF PROSTATE CANCER MTF ABBOTT IRELAND 29282FN00

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Disability ALNTY I PROCESSING MODU, 03R65-01, (B)(6).| ALNTY I PROCESSING MODU, 03R65-01, (B)(6).