BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® TPSA

    MDR report key: 8273896 · Received January 24, 2019

    Report

    Report Number
    8020790-2019-00002
    Event Type
    Malfunction
    Date Received
    January 24, 2019
    Report Date
    March 7, 2019
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LTJ
    PMA / PMN Number
    K010550
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL INVESTIGATION WAS PERFORMED FOR FALSELY OVER-ESTIMATED RESULTS WHEN TESTING THREE PATIENT SAMPLES IN ASSOCIATION WITH VIDAS® TPSA (TOTAL PROSTATE SPECIFIC ANTIGEN) LOT 1006670400. THE ANALYSIS OF THE BATCH HISTORY RECORDS FOR VIDAS TPSA REF 30428 LOT 1006670400/190623-0 SHOWED NO ANOMALY DURING THE MANUFACTURING , CONTROL AND PACKAGING PROCESSES, NOR NON-CONFORMITY LINKED TO CUSTOMER'S ISSUE. THE COMPLAINT TREND ANALYSIS CONFIRMED THERE WAS NO OTHER COMPLAINT ABOUT NOT REPRODUCIBLE RESULTS ON VIDAS TPSA REF 30428 LOT 1006670400/190623-0 CONTROL CHARTS ANALYSIS OBSERVED SEVEN INTERNAL SAMPLES (TARGET : 0.42- 26.70-4.86-0.38-4.42-20.80-4.74 NG/ML) ON SEVEN DIFFERENT BATCHES OF VIDAS TPSA REF 30428 INCLUDING THE CUSTOMER'S LOT 1006670400/190623-0. THE ANALYSIS OF THE CONTROL CHARTS SHOWED THAT ALL RESULTS ARE WITHIN SPECIFICATIONS, AND THE CUSTOMER'S LOT IS IN THE TREND OF THE OTHER LOTS. THE CUSTOMER'S SAMPLES WERE NOT SUBMITTED FOR EVALUATION. THE COMPLAINT LABORATORY TESTED THREE INTERNAL SAMPLES WITH THE RETAIN KIT VIDAS TPSA REF 30428 LOT 1006670400/190623-0. RESULTS FROM THE FIRST TEST AND SECOND TEST AFTER THREE DAYS WERE ALL WITHIN SPECIFICATION. AN INTERNAL SAMPLE WAS TESTED WITH SPR (SOLID PHASE RECEPTACLE) VIDAS FPSA , AND STRIP VIDAS TPSA WITH RESULTS OF 28.57 NG/L AND 2.14 NG/L. THE USE OF A FPSA SPR INSTEAD OF A TPSA SPR COULD EXPLAIN A DECREASE OF CONCENTRATION. IN CONCLUSION, THE ROOT CAUSE WAS NOT IDENTIFIED AS THE SAMPLES WERE NOT RECEIVED FROM THE CUSTOMER. WITHOUT SAMPLES IT WAS NOT POSSIBLE TO PURSUE FURTHER INVESTIGATION. IF THE OPERATOR USES A FPSA SPR INSTEAD OF A TPSA SPR, THERE COULD BE A DECREASE OF CONCENTRATION. VIDAS TPSA REF 30428 LOT 1006670400/190623-0 IS WITHIN THE EXPECTED PERFORMANCES.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED A FALSELY OVER-ESTIMATED RESULT WHEN TESTING THREE PATIENT SAMPLES IN ASSOCIATION WITH VIDAS® TPSA (TOTAL PROSTATE SPECIFIC ANTIGEN) LOT# 1006670400. THE INITIAL TEST RESULTS WERE REPORTED TO THE CLINICIAN AND DID NOT MATCH THE CLINICAL STATUS OF THE PATIENTS, SO RETESTING WAS REQUESTED. IT WAS REPORTED THAT REPEAT TESTS WERE PERFORMED IN THE SAME DAY BUT NOT IN THE SAME TIME AND SECTION OF THE INSTRUMENT. IT WAS NOTED THAT THESE TESTS WERE PERFORMED AFTER EXPIRATION DATE OF CALIBRATION. THE LAST CALIBRATION WAS PERFORMED ON (B)(6) 2018 AND WAS CONFORMING ON (B)(6) 2018. THE INTERNAL QUALITY CONTROL C1 WAS CONFORMING. THE CUSTOMER TESTED ALSO NEW SAMPLES FROM THE PATIENTS. PATIENT 1 : FIRST TEST :30.04 NG/ML. SECOND TEST: :0.49 NG/ML. NEW SAMPLE : 0.6 NG/ML. PATIENT 2: FIRST TEST :0.61 NG/ML. SECOND TEST: :4.63 NG/ML. NEW SAMPLE : 4.78 NG/ML. PATIENT 3: FIRST TEST :0.56 NG/ML. SECOND TEST: : N/A - LACK OF SAMPLE. NEW SAMPLE : 22.31 NG/ML. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69366 VIDAS® TPSA VIDAS® TPSA LTJ BIOMERIEUX SA 1006670400

    Patients

    Seq Age Sex Outcome Treatment
    1