BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL PSA

    MDR report key: 4045171 · Received August 28, 2014

    Report

    Report Number
    3008344661-2014-00033
    Event Type
    Malfunction
    Date Received
    August 28, 2014
    Date of Event
    August 7, 2014
    Report Date
    August 8, 2014
    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

    THE CUSTOMER REPORTED A FALSELY DEPRESSED TOTAL PSA PATIENT RESULT OF 85 NG/ML (MEASURED ON (B)(6) 2014) USING ARCHITECT TOTAL PSA 7K70-25 LOT 38558LF00) FOR A (B)(6) PROSTATE CANCER PATIENT UNDERGOING HORMONE THERAPY. THE SAMPLE FROM AUGUST WAS ALSO TESTED AT A REFERENCE LABORATORY AND A SIMILAR RESULT WAS OBTAINED. GOOD DILUTION LINEARITY WAS ALSO OBSERVED. THE CUSTOMER CONFIRMS THAT THE CONTROL VALUES WERE AS EXPECTED. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED. TESTING OF A SERUM BASED PANEL SAMPLE WITH A TARGET CONCENTRATION OF 32.4 NG/ML, WHICH MIMICS A PATIENT SAMPLE, WAS PERFORMED USING IN-HOUSE RETAINED KITS. ALL ACCEPTANCE SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER OBSERVATION. THE ARCHITECT TOTAL PSA REAGENT PACKAGE INSERT WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE. PER PRODUCT LABELING HORMONAL THERAPY MAY AFFECT PSA EXPRESSION; THEREFORE, A LOW PSA LEVEL AFTER ANY TREATMENT THAT INCLUDES HORMONAL THERAPY MAY NOT ADEQUATELY REFLECT THE PRESENCE OF RESIDUAL OR RECURRENT DISEASE. SPECIMENS FROM PATIENTS WHO HAVE RECEIVED PREPARATIONS OF MOUSE MONOCLONAL ANTIBODIES FOR DIAGNOSIS OR THERAPY MAY CONTAIN HUMAN ANTI-MOUSE ANTIBODIES (HAMA). SPECIMENS CONTAINING HAMA MAY PRODUCE ANOMALOUS VALUES WHEN TESTED WITH ASSAY KITS SUCH AS ARCHITECT TOTAL PSA THAT EMPLOY MOUSE MONOCLONAL ANTIBODIES. ARCHITECT TOTAL PSA REAGENTS CONTAIN A COMPONENT THAT REDUCES THE EFFECT OF HAMA REACTIVE SPECIMENS. THE INVESTIGATION DID NOT IDENTIFY A MALFUNCTION / DEFICIENCY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT ERRATIC ARCHITECT TOTAL PSA RESULTS WERE GENERATED ON A PROSTATE CANCER PATIENT. END OF 2013, 4.94 NG/ML. (B)(6) 2014, 36.25 NG/ML. (B)(6) 2014, 216 NG/ML. (B)(6) 2014, 172 NG/ML. (B)(6) 2014, 283 NG/ML. THE PATIENT WAS STARTED ON HORMONE THERAPY. (B)(6) 2014, 369 NG/ML. (B)(6) 2014, 85 NG/ML. THE CLINICAL DOCTOR QUESTIONED THE RESULTS AS THE VARIATION IN THE RESULTS IS TOO LARGE, ESPECIALLY FOR THE SAMPLE FROM AUGUST. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525316 ARCHITECT TOTAL PSA TOTAL PSA LTJ ABBOTT IRELAND 38558LF00

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR ARCHITECT I2000SR ANALYZER 3M74-01| ARCHITECT I2000SR ANALYZER 3M74-01| SN (B)(4)| SN (B)(4)