BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL PSA

    MDR report key: 15393497 · Received September 9, 2022

    Report

    Report Number
    3008344661-2022-00107
    Event Type
    Malfunction
    Date Received
    September 9, 2022
    Date of Event
    August 11, 2022
    Report Date
    November 8, 2022
    Manufacturer
    ABBOTT IRELAND
    Product Code
    MTF
    PMA / PMN Number
    P910007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALL AVAILABLE PATIENT INFORMATION IS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7K70 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 6C06. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ARCHITECT TOTAL PSA, 07K70-35, ABBOTT IRELAND - SLIGO TO ARCHITECT I2000SR, 03M74-02, ABBOTT LABORATORIES - IRVING, TEXAS. MDR NUMBER 3016438761-2022-00515-00 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER. H3 OTHER TEXT : AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ARCHITECT TOTAL PSA, 07K70-35, ABBOTT IRELAND - SLIGO TO ARCHITECT I2000SR, 03M74-02, ABBOTT LABORATORIES - IRVING, TEXAS. MDR NUMBER 3016438761-2022-00515-00 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY DECREASED ARCHITECT TOTAL PSA (PROSTATE SPECIFIC ANTIGEN) RESULT FOR A PATIENT WHILE USING THE ARCHITECT I2000SR ANALYZER. ON (B)(6) 2022, A PSA SAMPLE (SID (B)(6)) RESULT WAS > 100 NG/ML. THE SAMPLE WAS THEN AUTOMATICALLY DILUTED BY THE INSTRUMENT AND VALUE GENERATED TO BE < 0.08 NG/ML. SINCE THE CUSTOMER USES AUTO-VALIDATIONS OF RESULTS, THE < 0.08 NG/ML WAS RELEASED TO THE PATIENT. PATIENT/CLINICIAN QUESTIONED THE DECREASED RESULT AS IT DID NOT CORRELATE WITH THE PATIENT¿S CLINICAL PICTURE. A FRESH SAMPLE WAS COLLECTED FROM THE PATIENT AND RUN DIRECTLY WITH DILUTION PROTOCOL WHERE THE RESULT GENERATED A VALUE OF 540.665 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1139762 ARCHITECT TOTAL PSA TOTAL, PROSTATE SPECIFIC AG (NONCOMPLEXED/COMPLEXED) FOR DET OF PROSTATE CANCER MTF ABBOTT IRELAND 35138FN00

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ARC I2000SR INST, 03M74-02, (B)(6) | ARC I2000SR INST, 03M74-02, (B)(6)