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 Type  malfunction  

Event Description

Description of the issue.On (b)(6) 2022, a customer in portugal notified biomérieux of false negative result when testing with vidas® toxo igm 60 tests (ref.30202, lot #1008978850, expiry date: 10-jul-2022) in context of external quality control (qc).When testing the sample 1222 from the pnaeq, the customer obtained a negative result while the expected result was positive.As it was an external quality control no patient sample was involved.A biomérieux internal investigation has been 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 portugal that they obtained a false negative result when testing with vidas® toxo igm 60 tests (ref.30202, lot #1008978850, expiry date: 10-jul-2022) in context of external quality control (qc).Investigation ****************** device history record and complaint analysis as of the date of this investigation, review of the device history record and complaints database did not reveal evidence that this is a systemic quality issue.Control chart analysis was carried out on 4 internal sera (1 with negative target and 3 with positive targets), using 7 batches (including the lot mentioned by the customer).All results are within specifications and the customer lot is consistent with the other lots.Internal testing the complaints laboratory tested different internal samples (a negative sample and two positive samples) on the retain kit of vidas toxo igm customer lot 1008978850, lot 1009071870, and also compared to another batch with different raw material (lot 1009261020).All samples results are within their expected specifications and similar to those observed before the batch release.We do not observed any evolution over time of the lots of vidas toxo igm.Moreover, there is no significant difference of results between the different lots.Customer sample testing biomérieux received one (1) frozen aliquot sample (b)(6) from customer.The complaints laboratory tested the qc sample (1222) returned by customer on the retain kit of vidas toxo igm lot 1008978850 (mentioned by the customer) compared to another batch with different raw material (lot 1009261020).Qc sample (b)(6) was found negative on both lots (respectively 0.52 and 0.54 tv) external quality control sample analysis the complaints laboratory has access to reports from other quality control programs for vidas toxo igm results (ctcb and instand).For ctcb, the analysis of the results shows that detection of residual igm in the context of an old infection is variable depending on the reagents used.For instand, vidas results are similar to other methods.Conclusion according to all information above, no anomaly was highlighted with the trend analysis of internal samples, the analysis of quality data and the tests performed on our internal quality control materials on the retain kit of vidas toxo igm lot 1008978850.Biomérieux reproduced the negative results when testing the quality control sample (b)(6) on the different lots tested so the issue is not linked to a specific lot of vidas toxo igm.We have no information on the composition of this sample so we can not exclude a matrix effect; moreover, this sample is also positive on toxo igg so the positive results obtained by other methods could be due to residual igm.The clsi guideline ep14-a3 mentions that processed samples used as qc material (e.G eqa) can have matrix effect.¿current scientific data suggest that such use of pt/ eqa results is not always feasible because of matrix effects.These processed materials us as pt/ eqa samples sometimes do not behave like patient samples routinely analyzed in the laboratory.Biases not generally seen with fresh biological fluids, are frequently seen with pt / eqa samples¿.According to the data mentioned above, vidas toxo igm ref 30202 lot 1008978850 is within expected performance.

• 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: candace martin ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 14991155
• MDR Text Key: 302194206
• Report Number: 8020790-2022-00077
• Device Sequence Number: 1
• Product Code: LGD
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2022
• Device Catalogue Number: 30202
• Device Lot Number: 1008978850
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1