MAUDE Adverse Event Report: BIOMÉRIEUX SA VIDAS® TOXO IGG II

Catalog Number 30210

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2023

Event Type  malfunction  

Event Description

Product description: vidas® toxo igg ii is an automated quantitative test for use on the vidas® family instruments for the quantitative measurement of anti-toxoplasma igg in human serum or plasma (lithium heparin or edta) using the elfa technique (enzyme linked fluorescent assay).Issue description: on (b)(6) 23, a customer in france notified biomérieux of a potential false-negative patient result when using vidas® toxo igg ii reference 30210, lot 1009752570 (expiry 12-oct-2023).Initial patient result (b)(6) 2023 using vidas® toxo igg ii reference 30210, lot 1009752570: 0 iu/ml, negative.The same patient had follow-up testing (b)(6) 2023 using vidas® toxo igg ii reference 30210, lot 1009766490: 9 iu/ml, positive.Two (2) additional samples from this patient were tested using lot 1009766490: 8 iu/ml and 8 iu/ml, both results positive.Original sample from 01/26 retested using vidas® toxo igg ii reference 30210, lot 1009766490, (no re-centrifugation, just homogenization by hand after thawing): 10 iu/ml, positive.At the time of this assessment, there is no report of patient harm or incorrect treatment.The product, vidas® toxo igg ii reference 30210, is not marketed, sold or distributed in the united states.However, a similar product, vidas® toxo igg ii reference 30210-01 is marketed in the united states.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

This report was initially submitted following notification from a customer in france regarding a potential false-negative patient result when using vidas® toxo igg ii reference 30210 lot 1009752570 (expiry 12-oct-2023).A biomérieux internal investigation has been completed with the following results: investigation complaint analysis and device history record the review did not highlight any issue during manufacturing for this vidas txg ii reference 30210 lot 1009752570.There is no capa, no non conformity on vidas txg ii reference 30210 lot 1009752570 linked with customer 's issue.Until now, no similar complaints have been registered from the batch lot 1009752570.The analysis of the control charts performed on four (4) internal samples (with target 7.98 ui/ml; 12.0 ui/ml; 13.0 ui/ml and 16.4 ui/ml) and seven (7) batches including the one of customer showed that all results were within specifications.The customer¿s lot is in the trend of the other lots.Customer return the impacted sample.**testing was performed on internal samples** test performed with retain kit vidas txg ii ref 30210 lot 1009752570 on three (3) internal samples with target at 5 ui/ml, 12 ui/ml and 16 ui/ml.All the results were within specifications and similar to those obtained before the batch release.No evolution of vidas txg ii ref 30210 batch 1009752570 was observed.** tests on sample return** test performed with retain kits vidas txg ii ref 30210 lot 1009752570; 1009766490 (another lot used by the customer) and one other lot used as reference with different raw material 1009954970.Results : lot 1009752570 : 0 ui/ml negative lot 1009766490 : 10 ui/ml positive lot 1009954970 : 1 ui/ml negative customer anomaly was reproduced with vidas txg ii reference 30210 lot 1009954970.Since two out of three batches showed a negative result, the most likely hypothesis is that the sample interfered with the batch 1009766490.** interference research** additional tests were carried out on the sample returned by the customer.- sprs in which the coating of antibody was made from mouse - sprs in which the coating of antigen was not made from mouse - spiking with ascites to trap anti-mouse antibodies present in the serum the results of additional tests show potential interference with non-specific mouse ac present in the serum against component of the lot 1009766490.Root cause analysis in view of the above data, there is no doubt about the vidas txg ii reference 30210 vidas txg ii reference (b)(4) lots1009752570 and 1009766490 and their performance.The most likely hypothesis is potential interference with non-specific mouse ac present in the serum against component of the lot 1009766490.As mentioned in the ifu : interference may be encountered with certain sera containing antibodies directed against reagent components.For this reason, assay results should be interpreted taking into consideration the patient's clinical history and the results of any other tests performed.

• Brand Name: VIDAS® TOXO IGG II
• Type of Device: VIDAS® TOXO IGG II
• Manufacturer (Section D): BIOMÉRIEUX SA; 376 chemin de l'orme; marcy l'etoile 69280 ; FR 69280
• Manufacturer (Section G): BIOMÉRIEUX SA; 376 chemin de l'orme; marcy l'etoile 69280 ; FR 69280
• Manufacturer Contact: danielle cooper ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 16655322
• MDR Text Key: 313308697
• Report Number: 8020790-2023-00022
• Device Sequence Number: 1
• Product Code: LGD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K993319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2023
• Device Catalogue Number: 30210
• Device Lot Number: 1009752570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1