BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL PSA

    MDR report key: 2241617 · Received September 9, 2011

    Report

    Report Number
    1415939-2011-00567
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 22, 2011
    Report Date
    August 25, 2011
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LTJ
    PMA / PMN Number
    P910007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, ARCH TOTAL PSA, LIST (B)(4), THAT HAS A SIMILAR US PRODUCT DISTRIBUTED IN THE US, ARCH TOTAL PSA, LIST (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE DATE RECEIVED BY MANUFACTURER ON THE PREVIOUS SUBMISSION WAS INCORRECTLY LISTED AS (B)(4) 2011. THE CORRECT DATE IS (B)(4) 2011.

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, TESTING OF RETAINED REAGENT OF THE SAME LOT, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. ON (B)(6) 11 AN ACTIVE CALIBRATION WAS OBTAINED USING CALIBRATOR LOT 93389LF00 IN COMBINATION WITH LIKELY CAUSE REAGENT LOT 02229LF00. A REVIEW OF THE CUSTOMER'S QUALITY CONTROL DATA SHOWED THAT THE CONTROL LOT 81354LF00 USED AT THE TIME HAD EXPIRED ON 08 OCT 2010; HOWEVER EACH CONTROL RETURNED A CONCENTRATION WITHIN PACKAGE INSERT SPECIFICATIONS. THE MASTER LOT RELEASE TESTING DATA WAS REVIEWED AND ALL VALUES FOR CONTROLS WERE WITHIN THE SPECIFICATION RANGE. THERE WERE NO LAB INVESTIGATION REPORTS, NO NONCONFORMANCE REPORTS AND NO POTENTIAL NONCONFORMANCE REPORTS INITIATED DURING THE COURSE OF MANUFACTURE OF REAGENT LOT 02229LF00. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED AN ARCHITECT I2000SR ANALYZER GENERATED A FALSELY DECREASED TOTAL PSA RESULT FOR ONE PATIENT SAMPLE. ON (B)(6) 2011, THE ANALYZER GENERATED AN INITIAL TOTAL PSA RESULT OF 0.67 NG/ML. THE RESULT WAS QUESTIONED BASED ON THE PATIENT'S HISTORICAL TOTAL PSA VALUES. ON (B)(6) 2011, THE PATIENT WAS REDRAWN AND A TOTAL PSA RESULT OF 4.47 NG/ML WAS GENERATED. THE FIRST SAMPLE WAS THEN REPEATED AND A TOTAL PSA RESULT OF 4.96 NG/ML WAS GENERATED. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT TOTAL PSA LTJ ABBOTT LABORATORIES 02229LF00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH I2000SR LN 03M74-02 SN (B)(4)| ARCH I2000SR LN 03M74-02 SN (B)(4)| ARCH I2000SR LN 03M74-02 SN (B)(4)