BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL PSA

    MDR report key: 3061918 · Received April 16, 2013

    Report

    Report Number
    3008344661-2013-00020
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    April 10, 2013
    Manufacturer
    ABBOTT IRELAND
    Product Code
    LTJ
    PMA / PMN Number
    P910007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT LIST NUMBER 7K70 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE U.S., LIST NUMBER 6C06.

    Additional Manufacturer Narrative · 1

    FURTHER REVIEW OF THE CUSTOMER'S ISSUE INCLUDED A BATCH RECORD REVIEW AND LABELING REVIEW. AS THE LIKELY CAUSE REAGENT LOT EXPIRED IN NOV 2012 NO TESTING WAS PERFORMED. HOWEVER, A REVIEW OF THE MANUFACTURING RECORDS AND MASTERLOT TESTING RECORDS DID NOT IDENTIFY ANY ISSUES WITH THE REAGENT LOT. THERE ARE NO OTHER COMPLAINTS OF THIS NATURE FOR THIS REAGENT LOT AND NO ADVERSE TRENDS FOR THE PRODUCT. THE CUSTOMER STATED IN THE COMPLAINT THAT THE MOST LIKELY CAUSE FOR THE ELEVATED TOTAL PSA RESULT WAS DUE TO STIMULATION OF THE PATIENT'S PROSTATE PRIOR TO TAKING THE SAMPLE. IT IS STATED IN THE ARCHITECT TOTAL PSA REAGENT PACKAGE INSERT THAT PROSTATIC MASSAGE, ULTRASONOGRAPHY, AND NEEDLE BIOPSY MAY CAUSE CLINICALLY SIGNIFICANT ELEVATIONS OF TOTAL PSA. THIS INVESTIGATION CONCLUDES THAT ARCHITECT TOTAL PSA REAGENT 7K70-25 LOT 11259LF00 IS PERFORMING ACCEPTABLY. NO PRODUCT DEFICIENCY WAS IDENTIFIED AND NO ADDITIONAL ISSUES WERE IDENTIFIED DURING THE INVESTIGATION OF THIS COMPLAINT. THERE IS NOT ENOUGH INFORMATION TO REASONABLY SUGGEST A MALFUNCTION. INFORMATION IN THE TICKET SUGGESTS THAT THE ELEVATED RESULT IS ASSAY SPECIFIC AND NOT DUE TO A MALFUNCTION OF A SPECIFIC LOT /KIT.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED ONE PATIENT WITH A FALSELY ELEVATED TOTAL PROSTATE SPECIFIC ANTIGEN (PSA) RESULT ON THE ARCHITECT I1000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED: APRIL 2011: 1.0 NG/ML, APRIL 2012: INITIAL 18.8, RETEST 17.7 NG/ML AND (B)(6) 2013: 2.3 NG/ML. THE CUSTOMER IS QUESTIONING THE 2012 RESULTS. THERE WAS NO IMPACT TO PATIENT MANAGEMENT IN 2012 OR 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162217 ARCHITECT TOTAL PSA LTJ ABBOTT IRELAND 11259LF00

    Patients

    Seq Age Sex Outcome Treatment
    1 LN 01L86-01 SN (B)(4)| ARCHITECT I1000SR ANALYZER| ARCHITECT I1000SR ANALYZER| LN 01L86-01 SN (B)(4)