MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® TOXO IGM 60 TESTS

Catalog Number 30202

Device Problem False Negative Result (1225)

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

Event Date 05/25/2021

Event Type  malfunction  

Event Description

Intended use: vidas® toxo igm is an automated qualitative test for use on the vidas family instruments, for the detection of antitoxoplasma igm in serum using the elfa technique (enzyme linked fluorescent assay).Thresholds and interpretation of results: index interpretation i < 0.55 negative 0.55 = i < 0.65 equivocal i = 0.65 positive description of the issue: on (b)(6) 2021, a customer in martinique notified biomérieux of false negative result when testing with vidas® toxo igm 60 tests (ref.30202, lot #1008453220, expiry date: 27-sep-2021) in the context of external quality control (qc).The customer tested the ctcb sample number 2122 in (b)(6) 2021.This serum eqa sample came from a (b)(6) woman, pregnant (b)(6).The customer first used an alternate method (abbott diagnostic alignity toxo igm) and obtained positive result (0.62 with a cut-off at 0.6) when using the lot 1008453220, the customer obtained negative result (0.27 with a cut-off at 0.65).The expected result was positive.In routine analysis, the customer uses the vidas as confirmation technique after the alignity test.The customer specified that impact on patient would be limited because in case of discordance between both techniques, no conclusion on patient status is made and another test is performed two to three weeks after the first serology.All controls were good.As it was an external control quality sample, there is no patient sample involved.A biomérieux internal investigation will be initiated.Note: reference 30202 is not registered in the united states.The u.S.Similar device is product reference 30202-01.

Manufacturer Narrative

An internal investigation was performed following notification from a customer in martinique of false negative result when testing with vidas® toxo igm 60 tests (ref.(b)(4), lot #1008453220, expiry date: 27-sep-2021) in the context of external quality control (ctcb sample number 2122 in may 2021).Investigation ****************** 1.Device history record the review did not highlight any issue during manufacturing for vidas® toxo igm ref (b)(4) kit lot 1008453220.2.Complaint analysis the complaint analysis did not reveal this issue as a systemic quality issue.3.Tests/analysis performed **customer¿s materials** vidas® toxo igm ref 30202 lot 1008453220 was expired at the time of the customer notification and investigation, leading to the impossibility to perform test on the retain kit.However, the complaints laboratory participates in ctcb external quality control program as a user.This sample was tested with another vidas® toxo igm lot.**control charts analysis** the complaints laboratory analyzed the results of 4 internal samples, two negative and two positive on six different lots of vidas® toxo igm including customer¿s lot 1008453220.=> the analysis of the control charts showed that all results are within specifications.Customer¿s lot are in the trend of the other lots.**tests performed by complaint laboratory ** the complaints laboratory subscribes to ctcb external quality assessment program and tests those quality control samples such as an ordinary user.For this investigation, the complaints laboratory tested the same sample 2122 with another vidas® toxo igm lot 1008442120.Result obtained by the complaints laboratory(b)(6)2021: 0.34 tv close to the median peer group = 0.325 tv with z score = 0.589 conform.=> the complaints laboratory obtained a negative result as the customer.**analysis of ctcb report** in the report ctcb proficiency test: n°212 eeq toxoplasmose chapter 1: comments from expert stakeholders subchapter 1.2.Qualitative assigned values serum 2122 - presence of igg - presence of residual igm according to reagents under chapter 1.5.Quantitative results as observed during other campaigns, the detection of residual igm in the context of an old infection is variable depending on the reagents used.In a previous investigation in 2017, ie ctcb toxo 171, the sample 1711 has been found negative whereas it was expected to be positive with vidas® toxo igm reference 30202.The eqa ctcb 171, sample 1712, contains residual igm which are not detected by vidas technique.Vidas® toxo igm detects igm for a shorter period of time than other competitors.The cnr publication ( j.Clin.Microbiol.-2016-villard-3034-42.Pdf) mentioned by ctcb indicates : - a good sensibility of biomérieux vidas® toxo igm test ( 100% for accurate infection) - a low ability to detect residual igm antibodies.3.Root cause analysis and conclusion according to all information above, no anomaly was highlighted with the control chart analysis and the analysis of quality data.The complaints laboratory tested the same sample 2122 with another vidas® toxo igm lot 1008442120 and obtained a similar result, ie false negative.This phenomenon has been already described: - in a previous investigation with ctcb: ¿as observed during other campaigns, the detection of residual igm in the context of an old infection is variable depending on the reagents used.¿ - in an article: ¿j.Clin.Microbiol.-2016-villard-3034-42.Pdf¿.As a reminder of the package insert, in the chapter performance, acquired toxoplasmosis, it is mentioned: ¿[] 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%).Out of the 6 discrepant sera: []four corresponded to follow-up sera collected more than 8 weeks after the infection (residual igm).Two of these sera were also found to be negative with two other anti-toxoplasma igm detection techniques.¿ there is no reconsideration of the performance of vidas® toxo igm ref (b)(4) lot 1008453220 to its expectations.

• Brand Name: VIDAS® TOXO IGM 60 TESTS
• Type of Device: VIDAS® TOXO IGM 60 TESTS
• Manufacturer (Section D): BIOMERIEUX SA; 376 chemin de l'orme; marcy l'etoile 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX SA; 376 chemin de l¿orme; marcy l'etoile 69280 ; FR 69280
• Manufacturer Contact: romain marti ; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 13289466
• MDR Text Key: 286990195
• Report Number: 8020790-2022-00017
• Device Sequence Number: 1
• Product Code: LGD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K141133
• 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: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2021
• Device Catalogue Number: 30202
• Device Lot Number: 1008453220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1