MAUDE Adverse Event Report: BIOMERIEUX, SA VIDAS® TOXO IGM

Model Number 30202

Device Problem False Negative Result (1225)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer from (b)(6) notified biomérieux of obtaining a false negative result when testing ctcb sample 1812 with vidas® toxo igm (ref 30202).The expected result for this sample is positive.The summary of the survey results is as follows: vidas txm: 101 participants : 99% negative results and 1% positive results.Abbott architect and ortho vitro mostly found negative results.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to a patient's state of health.There was no patient associated with this survey sample.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer from france notified biomérieux of obtaining a false negative result when testing external quality control sample ctcb 1812 with vidas® toxo igm (txm), ref 30202.The expected result for this sample is positive.An internal biomérieux investigation was performed.For this quality control survey, there were 101 participants : 99% found negative results, and 1% found positive results.Two other assay techniques also give predominantly negative results.(abbott architect and ortho vitro).Per in the vidas txm package insert: since the persistence of anti-toxoplasma igm for several months or several years after seroconversion is a regularly described phenomenon, it is not possible to confirm recent infection based solely on the presence of anti-toxoplasma igm, without taking into account the serological history of the patient.Ctcb report: the igm level is at the limit of detection.These igm correspond to residual igm as shown by the high avidity results found on this sample.Control charts five internal sera , target: between 0.13 to 2.64 observed on 16 lots of vidas txm, including lot 180722-0 used by the laboratory claim during the first tests.The vidas txm lot 180722-0 is in the same trend as the other lots observed all the results are within specifications.Tests performed in complaints laboratory department: vidas txm lot 180722-0 (used by the laboratory claim during the tests) is no longer available.Ctcb 1812 and five internal sera, with target between 0.13 to 2.64, were tested on two lots: vidas txm 180730-0 and 190205-0 lots (with different raw material).The negative result for the ctcb 1812 was confirmed on the two lots.The results for the five internal samples tested on these two lots are in the expected standards and are similar.After comparing the results obtained now with respect to the batch release day, it was concluded that there has been no evolution of vidas txm reagents since their release.Conclusion : the negative result obtained was not linked to a specific vidas txm batch.Ctcb 1812 is confirmed negative with vidas txm lot 190205-0 and 180730-0 (two lots with different raw material).As mentioned by the ctcb report, the vidas txm technique does not detect residual igm, as shown by the high avidity at 0.514 (range >= 0.3 positive result) on this same serum.This is an old infection of toxoplasmosis.The vidas txm batches are within specification and intended performance of the product.

• Brand Name: VIDAS® TOXO IGM
• Type of Device: VIDAS® TOXO IGM
• Manufacturer (Section D): BIOMERIEUX, SA; 376 chemin de l'orme; marcy l'etoile, 69280 ; FR 69280
• MDR Report Key: 7694592
• MDR Text Key: 114715993
• Report Number: 3002769706-2018-00106
• Device Sequence Number: 1
• Product Code: LGD
• Combination Product (y/n): N
• PMA/PMN Number: K923166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 30202
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1