BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHITECT TOTAL PSA

    MDR report key: 2073397 · Received May 1, 2011

    Report

    Report Number
    1628664-2011-00211
    Event Type
    Injury
    Date Received
    May 1, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 7, 2011
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LTJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INITIAL REPORT WAS SUBMITTED UNDER BRAND NAME ABBOTT ARCHITECT I1000 ANALYZER, IRVING TX MANUFACTURING SITE. IT WAS DETERMINED THAT THE INVESTIGATION SHOULD BE PERFORMED ON BRAND NAME ARCHITECT TOTAL PSA REAGENT, (B)(4). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7K70 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 6C06. AS THE LOT NUMBER OF THE ARCHITECT TOTAL PSA REAGENT WAS UNKNOWN AND NO RECORDS REMAIN ON THE INSTRUMENT A SIX MONTH REVIEW OF THE ARCHITECT TOTAL PSA QUALITY TESTING DATA WAS PERFORMED ((B)(6) 2010 - (B)(6) 2011). THE RECORDS WERE ANALYZED AND NO PERFORMANCE ISSUES WERE IDENTIFIED. IN ADDITION, THERE WERE NO TRENDS OBSERVED. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED. THE ARCHITECT TOTAL PSA REAGENT PACKAGE INSERT WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE OF ERRATIC RESULTS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT THE ARCHITECT I1000 HAS GENERATED SEVERAL ELEVATED TOTAL PSA RESULTS ON A PATIENT. ON (B)(6) 2010 A TOTAL PSA RESULT OF 115.4 NG/ML WAS GENERATED AND A FREE PSA RESULT WAS 3.9%. ON (B)(6) 2011 A TOTAL PSA RESULT OF 113.6 NG/ML WAS GENERATED. ON (B)(6) 2011 A TOTAL PSA RESULT OF 124.5 NG/ML WAS GENERATED. THE PATIENT UNDERWENT A BIOPSY AS A RESULT OF THE ELEVATED PSA RESULTS. THE BIOPSY RESULTS WERE NEGATIVE.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Disability ARCHITECT I1000SR 1L86-01 (B)(4)| ARCHITECT TOTAL PSA LN 7K70 LOT UNKNOWN