BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHITECT TOTAL PSA

    MDR report key: 1982604 · Received February 9, 2011

    Report

    Report Number
    1415939-2011-00027
    Event Type
    Injury
    Date Received
    February 9, 2011
    Report Date
    January 12, 2011
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LTJ
    PMA / PMN Number
    P910007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT (ARCHITECT TOTAL PSA, LIST 7K70) THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US (ARCHITECT TOTAL PSA, LIST 6C06). USING ARCHITECT TOTAL PSA REAGENT LIST 7K70-25 LOT 91572LF00 AND AN APPROVED IN-HOUSE LOT OF CALIBRATORS AND CONTROLS, PERFORMANCE TESTING WAS CONDUCTED. FIFTEEN REPLICATES EACH OF TWO DIFFERENT CONCENTRATIONS OF IN-HOUSE SERUM BASED SAMPLES WERE USED FOR TESTING. THESE SAMPLES WERE USED TO ASSESS THE REAGENT PERFORMANCE AT THE UPPER AND LOWER RANGE OF THE ASSAY. AN APPROVED LOT OF IN-HOUSE CALIBRATORS AND CONTROLS WERE USED TO ASSESS THE VALIDITY AND ACCEPTANCE OF THE CALIBRATION. RESULTS OBTAINED WERE WITHIN EXPECTED VALUES AND PASSING ACCEPTANCE CRITERIA. TESTING CONFIRMED THAT ARCHITECT TOTAL PSA LIST 7K70-25 LOT 91572LF00 IS PERFORMING ACCEPTABLY. IN ADDITION, TESTING DATA GENERATED PRIOR TO APPROVAL OF THIS REAGENT LOT AND THE MANUFACTURING RECORDS WERE REVIEWED. NO ISSUES WERE IDENTIFIED AND THE KIT RELEASE SPECIFICATIONS WERE MET. MANUFACTURING RECORDS WERE ALSO REVIEWED AND NO ISSUES WERE IDENTIFIED. A REVIEW OF COMPLAINT REPORT RECORDS WAS PERFORMED. THERE IS NO ADVERSE TREND FOR THIS PRODUCT. BASED ON THE INVESTIGATION, IT WAS DETERMINED THAT ARCHITECT TOTAL PSA REAGENT LIST 7K70-25 LOT 91572LF00 IS PERFORMING ACCEPTABLY. NO PRODUCT DEFICIENCY FOR THE ARCHITECT TOTAL PSA ASSAY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT AN ARCHITECT TOTAL PSA RESULT OF 141 NG/ML WAS REPORTED FOR A (B)(6) YEAR OLD MALE PATIENT. A BIOPSY WAS PERFORMED AND NO TUMOR WAS OBSERVED. THE CUSTOMER SUSPECTS THE TOTAL PSA RESULT TO BE FALSELY ELEVATED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT TOTAL PSA FOR THE DETERMINATION OF TOTAL PROSTATE SPECIFIC ANTIGEN (PSA) LTJ ABBOTT LABORATORIES 91572LF00

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Disability ARCHITECT I1000SR LN: 1L86, SERIAL: (B)(4)