BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® TPSA

    MDR report key: 5808579 · Received July 20, 2016

    Report

    Report Number
    3002769706-2016-00121
    Event Type
    Malfunction
    Date Received
    July 20, 2016
    Report Date
    May 12, 2016
    Manufacturer
    BIOMERIEUX SA
    Product Code
    MTF
    PMA / PMN Number
    P040008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION THAT A CUSTOMER IN (B)(6)REPORTED VIDAS® TPSA RESULTS ARE LOWER THAN EXPECTED FOR TWO PATIENTS. BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. REVIEW OF COMPLAINT RECORDS INDICATED THERE IS NO OTHER COMPLAINT FOR THE SAME ISSUE ON THE BATCH VIDAS TPSA LOT 1004597150 / 170106-0. EVALUATION OF THE MANUFACTURING BATCH RECORD FOR THE REFERENCED LOT INDICATED NO ANOMALY ASSOCIATED WITH THE BATCH. INVESTIGATIONAL TESTING INCLUDED FOUR (4) SAMPLES PROCESSED WITH VIDAS® TPSA LOT 170160-0; ALL RESULTS WERE WITHIN SPECIFICATION AND HAD NOT CHANGED SINCE LOT RELEASE 16-FEB-2016. WITHOUT CUSTOMER SUBMITTAL OF THE PATIENT SAMPLES, NO FURTHER TESTING IS POSSIBLE. THE PERFORMANCE OF VIDAS® TPSA BATCH 1004597150 / 170106-0 IS WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF DISCREPANT RESULTS WITH THE VIDAS TPSA (REFERENCE 30428). THE CUSTOMER REPORTED TWO (2) DIFFERENT PATIENT RESULTS THAT ARE LOWER THAN RESULTS OBTAINED IN THE PAST; HOWEVER, REFERENCE LAB RESULTS WERE HIGHER THAN PAST PATIENT RESULTS. THE CUSTOMER REPORTS PATIENT RESULTS OF 0.22 NG/ML AND 0.25 NG/ML UTILIZING THE SAME BATCH NUMBER AND CALIBRATION; IN ADDITION, THE SAME PATIENT RESULTS OF <0.07 NG/ML AND 1.25 NG/ML WERE OBTAINED UTILIZING THE SAME BATCH NUMBER AND A DIFFERENT CALIBRATION. THE CUSTOMER REPORTS THAT THE SAMPLES WERE SENT TO A REFERENCE LAB WHERE ONE OF THE PATIENT SAMPLE RESULTS WAS ABOUT 5 NG/ML. THE CUSTOMER REPORTS THAT AN ANALYSIS WAS MADE ON ALL POSITIONS OF THE INSTRUMENT USING ONLY ONE SAMPLE OF A COMPLETELY DIFFERENT PATIENT; HOWEVER, ALL RESULTS WERE IDENTICAL. AN INTERNAL BIOMERIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463202 VIDAS® TPSA VIDAS® TPSA MTF BIOMERIEUX SA 1004597150

    Patients

    Seq Age Sex Outcome Treatment
    1