BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® TOXO IGM

    MDR report key: 6024129 · Received October 12, 2016

    Report

    Report Number
    3002769706-2016-00442
    Event Type
    Malfunction
    Date Received
    October 12, 2016
    Report Date
    February 28, 2017
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LGD
    PMA / PMN Number
    K923166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER NOTIFIED BIOMERIEUX THAT THEY HAD A DISCREPANT RESULT WHEN USING THE VIDAS® TOXO IGM TEST KIT. A PATIENT SAMPLE WAS IDENTIFIED AS NEGATIVE FOR TOXO IGM. FURTHER TESTING BY A SECONDARY LABORATORY DETERMINED THE SAMPLE POSITIVE FOR TOXO IGM. THERE WAS A DELAY OF APPROXIMATELY ONE DAY IN TRANSMITTING THE RESULT TO THE HEALTHCARE PROFESSIONAL. AN INTERNAL BIOMERIEUX INVESTIGATION WAS CONDUCTED. A REVIEW OF THE BATCH HISTORY RECORD OF VIDAS TOXO IGM LOT 1004792810/170129-0 RESULTED IN NO FINDINGS OF COMPLAINTS, NON-CONFORMANCES, OR CAPAS. FIVE (5) INTERNAL SAMPLES WERE REVIEWED FOR 6 DIFFERENT BATCHES VIDAS TOXO IGM. (TARGET : 0.06VT, 0.79 VT, 2.51 VT, 0.85 VT AND 1.25 VT). THE VIDAS TOXO M LOT 1004792810/170129-0 WAS IN THE TREND OF THE OTHER OBSERVED BATCHES. THESE 5 INTERNAL SAMPLES WERE TESTED ON VIDAS TOXO M LOT 170129-0 AND LOT 170718-0. THE RESULTS OBTAINED FOR THE INTERNAL SERA WERE SIMILAR FOR BOTH BATCHES. THE QUALITY PRODUCT LABORATORY TESTED THE RETURNED CUSTOMER SAMPLE AND CONFIRMED THE CUSTOMER RESULT: VIDAS TOXO IGM LOT 170129-0 (CUSTOMER BATCH): 0.41 VT : NEGATIVE RESULT. VIDAS TOXO IGM LOT 170718-0 (OTHER BATCH): 0.37 VT : NEGATIVE RESULT. VIDAS TOXO IGG II LOT 170606-0 : 8 UI/ML : LOW POSITIVE RESULT. VIDAS TOXO IGG AVIDITY LOT 170722-0: 0.351 : HIGH. AN AVIDITY INDEX HIGHER OR EQUAL TO 0.300 IS STRONGLY IN FAVOR OF A PRIMARY INFECTION DATING BACK OVER 4 MONTHS. TO CONFIRM THE CUSTOMER RESULTS , THE QUALITY PRODUCT LABORATORY TESTED THE RETURN SERA WITH TOXO ISAGA AND TOXO ISAGA IGA. THE RESULT WAS POSITIVE FOR THE 2 TESTS. ACCORDING TO THE ANALYSIS CARRIED OUT BY OUR EXPERTS, THIS SERUM HAS AN ATYPICAL PROFILE. IT IS IMPOSSIBLE TO RULE OUT A RECENT INFECTION. IT IS ESSENTIAL TO PLAN A SEROLOGICAL TEST ON A 2ND SAMPLING IN 4 WEEKS. THE RELATIVE SENSITIVITY OF SERA FROM PREGNANT WOMEN WHO WERE IN CONTACT WITH TOXOPLASMOSIS DURING THEIR PREGNANCY IS 96.00% (95% CONFIDENCE INTERVAL: 91.43-98.18%). THE RESULT OF 1 FALSE POSITIVE FOR 1273 KITS RELEASED, SO A SENSITIVITY AT 99,99 %, THE SENSITIVITY IS CONSISTENT TO THE EXPECTED PERFORMANCE. VIDAS TOXO IGM LOT 1004792810/170129-0 IS IN THE EXPECTED PERFORMANCE AS WRITTEN IN THE PACKAGE INSERT.

    Additional Manufacturer Narrative · 1

    A CUSTOMER NOTIFIED BIOMERIEUX THAT THEY HAD A DISCREPANT RESULT WHEN USING THE VIDAS® TOXO IGM TEST KIT. A PATIENT SAMPLE WAS IDENTIFIED AS NEGATIVE FOR TOXO IGM. FURTHER TESTING BY A SECONDARY LABORATORY DETERMINED THE SAMPLE POSITIVE FOR TOXO IGM. THERE WAS A DELAY OF APPROXIMATELY ONE DAY IN TRANSMITTING THE RESULT TO THE HEALTHCARE PROFESSIONAL. AN INTERNAL BIOMERIEUX INVESTIGATION WAS CONDUCTED. A REVIEW OF THE BATCH HISTORY RECORD OF VIDAS TOXO IGM LOT 1004792810/170129-0 RESULTED IN NO FINDINGS OF COMPLAINTS, NON-CONFORMANCES, OR CAPAS. FIVE (5) INTERNAL SAMPLES WERE REVIEWED FOR 6 DIFFERENT BATCHES VIDAS TOXO IGM. (TARGET : 0.06VT, 0.79 VT, 2.51 VT, 0.85 VT AND 1.25 VT). THE VIDAS TOXO M LOT 1004792810/170129-0 WAS IN THE TREND OF THE OTHER OBSERVED BATCHES. THESE 5 INTERNAL SAMPLES WERE TESTED ON VIDAS TOXO M LOT 170129-0 AND LOT 170718-0. THE RESULTS OBTAINED FOR THE INTERNAL SERA WERE SIMILAR FOR BOTH BATCHES. THE QUALITY PRODUCT LABORATORY TESTED THE RETURNED CUSTOMER SAMPLE AND CONFIRMED THE CUSTOMER RESULT: VIDAS TOXO IGM LOT 170129-0 (CUSTOMER BATCH): 0.41 VT: NEGATIVE RESULT, VIDAS TOXO IGM LOT 170718-0 (OTHER BATCH): 0.37 VT: NEGATIVE RESULT, VIDAS TOXO IGG II LOT 170606-0: 8 UI/ML: LOW POSITIVE RESULT, VIDAS TOXO IGG AVIDITY LOT 170722-0: 0.351: HIGH. AN AVIDITY INDEX HIGHER OR EQUAL TO 0.300 IS STRONGLY IN FAVOR OF A PRIMARY INFECTION DATING BACK OVER 4 MONTHS. TO CONFIRM THE CUSTOMER RESULTS , THE QUALITY PRODUCT LABORATORY TESTED THE RETURN SERA WITH TOXO ISAGA AND TOXO ISAGA IGA. THE RESULT WAS POSITIVE FOR THE 2 TESTS. ACCORDING TO THE ANALYSIS CARRIED OUT BY OUR EXPERTS, THIS SERUM HAS AN ATYPICAL PROFILE. IT IS IMPOSSIBLE TO RULE OUT A RECENT INFECTION. IT IS ESSENTIAL TO PLAN A SEROLOGICAL TEST ON A 2ND SAMPLING IN 4 WEEKS. THE RELATIVE SENSITIVITY OF SERA FROM PREGNANT WOMEN WHO WERE IN CONTACT WITH TOXOPLASMOSIS DURING THEIR PREGNANCY IS 96.00% (95% CONFIDENCE INTERVAL: 91.43-98.18%). THE RESULT OF 1 FALSE POSITIVE FOR 1273 KITS RELEASED, SO A SENSITIVITY AT 99,99 %, THE SENSITIVITY IS CONSISTENT TO THE EXPECTED PERFORMANCE. VIDAS TOXO IGM LOT 1004792810/170129-0 IS IN THE EXPECTED PERFORMANCE AS WRITTEN IN THE PACKAGE INSERT.

    Description of Event or Problem · 1

    A CUSTOMER NOTIFIED BIOMERIEUX THAT THEY HAD A DISCREPANT RESULT WHEN USING THE VIDAS® TOXO IGM TEST KIT. A PATIENT SAMPLE WAS IDENTIFIED AS NEGATIVE FOR TOXO IGM. FURTHER TESTING BY A SECONDARY LABORATORY DETERMINED THE SAMPLE POSITIVE FOR TOXO IGM. WHEN SPECIFICALLY ASKED, NO INJURY OR DEATH HAPPENED AS A RESULT OF THIS EVENT. THE CUSTOMER DID INDICATE A DELAY OF APPROXIMATELY ONE DAY IN TRANSMITTING THE RESULT TO THE HEALTHCARE PROFESSIONAL AS A RESULT OF THIS EVENT. AN INVESTIGATION HAS BEEN INITIATED BY BIOMERIEUX TO INVESTIGATE THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672707 VIDAS® TOXO IGM VIDAS® TOXO IGM LGD BIOMERIEUX SA 1004792810

    Patients

    Seq Age Sex Outcome Treatment
    1