BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® TOXO IGG II

    MDR report key: 7276856 · Received February 16, 2018

    Report

    Report Number
    3002769706-2018-00017
    Event Type
    Malfunction
    Date Received
    February 16, 2018
    Report Date
    April 3, 2018
    Manufacturer
    BIOMERIEUX, SA
    Product Code
    LGD
    PMA / PMN Number
    K993319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER IN SLOVENIA NOTIFIED BIOMÉRIEUX OF A FALSE NEGATIVE RESULT ASSOCIATED WITH VIDAS® IGG II (REFERENCE 30210). AN INVESTIGATION WAS PERFORMED. A REVIEW OF QUALITY RECORDS CONFIRMED THERE WERE NO ISSUES ASSOCIATED WITH THE MANUFACTURE OF VIDAS TXGII LOT 1005736800 / 180416-0. FIVE (5) INTERNAL SAMPLES ( TWO (2) NEGATIVE SAMPLES, AND THREE (3) POSITIVE SAMPLES WITH TARGETS CLOSE TO THE SAMPLE VALUES OBTAINED BY THE CUSTOMER: FROM 62 IU/ML TO 69.60 IU/ML) WERE TESTED ON THE VIDAS TXGII LOT 1005736800. THE RESULTS OBTAINED FOR THE FIVE (5) SAMPLES WERE WITHIN THEIR EXPECTED SEROLOGICAL STATUS, AND THE RESULTS OBTAINED ARE SIMILAR TO THOSE OBTAINED BY THE QUALITY CONTROL LABORATORY DURING THE KIT'S ACTIVITY CONTROL. THE CUSTOMER'S ISSUE WAS NOT REPRODUCED ON THE INTERNAL SAMPLES. THE ANALYSIS OF THESE FIVE (5) INTERNAL SAMPLES CHARTED WITH SEVEN (7) DIFFERENT BATCHES OF VIDAS TXG II, INCLUDING CUSTOMER LOTS (VIDAS TXG II 180416-0, 180613-0 AND 180801-0) SHOWED THAT THE VIDAS TXG II LOT 1005736800 / 180416-0 IS IN THE TREND OF THE OTHER BATCHES. ACCORDING TO THE DATA MENTIONED ABOVE, VIDAS TXG II LOT 1005736800 / 180416-0 IS WITHIN THE EXPECTED PERFORMANCES. TESTS WERE PERFORMED ON THE VIDAS TOXO IGG KIT TO SIMULATE AN OPERATOR ERROR . WITHOUT A SAMPLE DISPENSED IN THE FIRST WELL OF THE VIDAS STRIP, OR WITHOUT SPR LOADED IN THE SPR BLOCK, A DECREASE OF THE SIGNAL AND TEST VALUE UP TO 0 (0 RFV / 0 UI/ML LEADING TO A NEGATIVE SEROLOGICAL STATUS) WAS OBSERVED FOR A POSITIVE SAMPLE (2092 RFV EXPECTED). WITH A RESULT AT 25 RFV AND 0 UI/ML FOR THE "619" SAMPLE , WE CANNOT CONCLUDE TO THIS POSSIBILITY. TESTED MISHANDLING BY INVERSION OF SPR WITH TOXOM SPRS USED, INSTEAD OF TXO IGG SPRS. A RESULT OF 18 IU/ML (910 RFV) WAS OBTAINED ON C1 (EXPECTED VALUE 40IU/ML & 1522 RFV), TESTED A SAMPLE MIX DISPENSED TWICE. THE SAMPLE NAMED NUMBER "620" TESTED TWICE IN POSITIONS A3 AND A4 . SIMILAR RESULTS AT 0UI/ML BUT WITH RESPECTIVELY 25 RFV AND 19 RFV. WITHOUT RETURN OF THE SAMPLE IT IS IMPOSSIBLE TO PURSUE FURTHER INVESTIGATION. IN CONCLUSION, THE ROOT CAUSE CANNOT BE DETERMINED. FOR SEROLOGY, AND ESPECIALLY FOR TOXOPLASMOSIS, THE BEHAVIOR OF IMMUNOGLOBULINS PRESENTATION FOR IMMUNOASSAY TESTS CAN BE DIFFERENT AND IS CLOSELY LINKED TO SAMPLES. EXPECTED VIDAS PERFORMANCES CAN BE REACHED BY FOLLOWING BEST PRACTICES: PRE-ANALYTICAL STEPS, VIDAS MAINTENANCE (QCV), AND THE USER CHECKPOINTS INDICATED IN THE PACKAGE INSERTS AND USER MANUAL.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A FALSE NEGATIVE RESULT ASSOCIATED WITH VIDAS® IGG II (REFERENCE 30210). THE CUSTOMER REPORTED A PREGNANT PATIENT WAS TESTED IN (B)(6) AND THE RESULT WAS 0 IU/ML (25 RFV SAMPLE (B)(6)). THE SAME PATIENT SAMPLE ((B)(6)) WAS RETESTED ON (B)(6) 2017 AND THE RESULT WAS 61 IU/ML. A NEW SAMPLE FROM THE SAME PATIENT ((B)(6)) WAS TESTED ON (B)(6) 2017 AND THE RESULT WAS 77 IU/ML AND RETESTED ON (B)(6) 2017 WITH THE RESULT OF 57 IU/ML. ALL VIDAS® TOXO IGM RESULTS WERE NEGATIVE FOR BOTH SAMPLES. THE RESULTS WERE REPORTED TO THE PHYSICIAN. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122230 VIDAS® TOXO IGG II VIDAS® TOXO IGG II LGD BIOMERIEUX, SA 1005736800

    Patients

    Seq Age Sex Outcome Treatment
    1