BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® TOXO IGG II

    MDR report key: 6952225 · Received October 16, 2017

    Report

    Report Number
    3002769706-2017-00303
    Event Type
    Malfunction
    Date Received
    October 16, 2017
    Date of Event
    May 30, 2017
    Report Date
    December 28, 2017
    Manufacturer
    BIOMERIEUX, SA
    Product Code
    LGD
    PMA / PMN Number
    K993319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOM¿RIEUX OF A FALSE POSITIVE RESULT WHEN USING THE PRODUCT VIDAS¿ TOXO IGG II. THE CUSTOMER SUBMITTED THE SERUM FOR EVALUATION. AN INVESTIGATION WAS PERFORMED. THE COMPLAINT LABORATORY TESTED 5 INTERNAL SAMPLES ( 3 NEGATIVE SAMPLES, 1 EQUIVOCAL AND 1 POSITIVE SAMPLE) ON THE VIDAS TXGII LOT 1005508950 /180103-0 : G238 : 0 UI/ML FOR MEAN 0.11 UI/ML AND RANGE [0.0-0.43] UI/ML. G263 : 4 UI/ML FOR MEAN 3.87 UI/ML AND RANGE [2.32-5.42] UI/ML. G300 : 0 UI/ML FOR MEAN 0.17 UI/ML AND RANGE [0.0-0.51] UII/ML. G256 : 5 UI/ML; FOR MEAN 5.03 UI/ML AND FOR RANGE [3.09-6.97] UI/ML. G248: 35 UI/ML; FOR MEAN 33.7 UI/ML AND FOR RANGE [22.3-45.1] UI/ML. THE RESULT OBTAINED FOR THESE 5 SAMPLES WERE WITHIN THEIR EXPECTED SPECIFICATIONS. THE COMPLAINT LABORATORY OBSERVED THESES 5 SAMPLES ON 8 DIFFERENT BATCHES VIDAS TXG II, INCLUDING LOT 180103-0 : THE VIDAS TXG II LOT 1005508950 / 180103-0 IS IN THE TREND OF THE OTHER BATCHES. THE RETURN SAMPLE WAS SENT TO AN EXTERNAL EXPERT LABORATORY OF TOXOPLASMOSISE. SAMPLE OF (B)(6) 2017 : ARCHITECT IGG, 1.40 UI/ML ( POS>= 3 UI/ML) , NEGATIVE RESULT. ARCHITECT IGM, 0.06 ( POS >=0.6) , NEGATIVE RESULT. VIDAS IGG,12.0 UI/ML ( POS >=8 UI/ML), POSITIVE RESULT. VIDAS IGM,0.04 UI/ML ( POS >=0.65), NEGATIVE RESULT. WESTERN BLOT LDBIO-TOXO II IGG : 1 SPECIFIC BAND AT 30KDA . SAMPLE OF (B)(6) 2017 : ARCHITECT IGG, 1.90 UI/ML ( POS>= 3 UI/ML) , EQUIVOCAL RESULT. ARCHITECT IGM, 0.06 ( POS >=0.6) , NEGATIVE RESULT. VIDAS IGG,12.0 UI/ML ( POS >=8 UI/ML), POSITIVE RESULT. VIDAS IGM,0.04 UI/ML ( POS >=0.65), NEGATIVE RESULT. WESTERN BLOT LDBIO-TOXO II IGG : 1 SPECIFIC BAND AT 30KDA. THE EXPERT CONFIRMED : WITH VIDAS METHOD: THE PRESENCE OF IGG. THE ABSENCE OF IGM. ARCHITECT METHOD GIVES A NEGATIVE RESULT OR AN EQUIVOCAL RESULT FOR THE 2ND SAMPLE (31/7) FOR TOXO IGG AND NEGATIVE RESULT FOR TOXO IGM ON BOTH SAMPLES WESTERN BLOT TOXO IGG (LDBIO-TOXO II IGG) WITH A SPECIFIC BAND AT 30KDA , THE RESULT HAS TO BE CONSIDERED AS NEGATIVE . THESE RESULTS DID NOT ALLOW US TO CONCLUDE TO THE PRESENCE OF SPECIFIC IGG AND IN THIS CONTEXT, THE PATIENT HAS TO BE CONSIDERED AS NON OR NOT ENOUGH IMMUNIZED FOR A NEXT PREGNANCY, IT IS RECOMMEND TO A FOLLOW THE TOXOPLASMA SEROLOGY OF THE PATIENT. THE EXPERT CONCLUDED TWO HYPOTHESIS : "FIRST, A VERY LOW IMMUNIZATION WITH A SPECIFIC IGG RATE CLOSE TO THE POSITIVE THRESHOLD OF VIDAS AND ARCHITECT TECHNIQUES. EVEN IF THE WESTERN BLOT IGG2 WAS NEGATIVE, A 30KDA BAND WAS DETECTED WHICH CORRESPONDS TO ONE OF THE PREDOMINANT PROTEINS OF TOXOPLASMA GONDII. PRESENCE OF NON-SPECIFIC IGG DETECTED BY VIDAS TECHNIQUE (POSITIVE RATE) AND BY ARCHITECT TECHNIQUE (EQUIVOCAL RATE). IN FINE THE WESTERN BLOT IGG2; CURRENT TEST FOR CONFIRMATION, IS INTERPRETED AS NEGATIVE". THE ROOT CAUSE OF THIS ISSUE IS PROBABLY DUE TO THIS SPECIFIC SAMPLE. ACCORDING TO THE DATA MENTIONED ABOVE, VIDAS TXG II LOT 1005508950 / 180103-0 IS WITHIN THE EXPECTED PERFORMANCES.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOM¿RIEUX OF A FALSE POSITIVE RESULT WHEN USING THE PRODUCT VIDAS¿ TOXO IGG II (REF. 30210), LOT 1005508950. THE PATIENT IS A FEMALE WHO WAS PREGNANT AND GAVE BIRTH ON (B)(6) 2017. THE CUSTOMER REPORTED THAT THE PATIENT HAD SERUM TESTED PRIOR TO DELIVERY, ON (B)(6) 2017, WHICH OBTAINED TOXOPLASMA SERONEGATIVE RESULTS VIA THE ARCHITECT SYSTEM. THESE TESTS INCLUDED: IGG ARCHITECT (1.4 UI/ML - NEGATIVE), IGM ARCHITECT (0.08). AS THE PATIENT HAD A NEGATIVE SEROLOGY IN (B)(6) AND GAVE BIRTH ON (B)(6) 2017, SHE DID NOT HAVE GAMMA GLOBULIN OR TRANSFUSION. IN MAY, TESTING WITH VIDAS¿ TOXO IGG HAD NOT BEEN DONE. PER THE CUSTOMER'S PROTOCOL, THE PATIENT WAS TESTED AGAIN ONE MONTH AFTER DELIVERY. ON (B)(6) 2017, THE FOLLOWING RESULTS WERE OBTAINED: IGG ARCHITECT (1.9 UI/ML - EQUIVOCAL), IGM ARCHITECT (0.07), VIDAS¿ TOXO IGG II (13.0 UI/ML - POSITIVE), VIDAS¿ TOXO TXC (0.97 - POSITIVE), WESTERN BLOT IGG II (P30,31 - NEGATIVE). THE CUSTOMER RE-TESTED THE (B)(6) 2017 PATIENT SAMPLE USING VIDAS¿, AND BIOM¿RIEUX RECEIVED THE RESULTS ON (B)(6) 2017: VIDAS¿ TOXO IGG II (9.0 UI/ML - POSITIVE), VIDAS¿ TOXO TXC (1.18 - POSITIVE). THE CUSTOMER STATED NO DELAY GREATER THAN ONE WEEK IN REPORTING PATIENT RESULTS. THEY STATED THAT THERE WERE NO WRONG RESULTS REPORTED TO A PHYSICIAN, AND THERE WAS NO INCORRECT TREATMENT OR HARM TO THE PATIENT BASED UPON THE VIDAS¿ RESULT. A BIOM¿RIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732369 VIDAS® TOXO IGG II VIDAS® TOXO IGG II LGD BIOMERIEUX, SA 1005508950

    Patients

    Seq Age Sex Outcome Treatment
    1