MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® TOXO IGM

Catalog Number 30202

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer in (b)(6) reported to biomérieux that they have observed false negative results, as part of eeq ctcb 1632, in association with the vidas® toxo igm test.The customer indicated the serum is a known positive and the test results were: result obtained : 0.48 => negative.The test results and ctcb report was requested from the customer.An internal biomérieux investigation has been initiated.

Manufacturer Narrative

A customer in (b)(6) reported to biomérieux that they have observed false negative results, as part of eeq ctcb 1632, in association with the vidas® toxo igm test.An internal biomérieux investigation was performed.Results for this control ctcb toxo 163 are as follows : -four (4) participants gave a positive result as expected, -31 participants gave an equivocal result, -84 participants gave a negative result.Since january 2015, there has been no recurrence on a specific batch of vidas® toxo igm for an external quality problem.The study of batch history record for vidas® toxo igm lots 1004881890 / 170306-0, 1004702590 / 161202-0 et 1005939820 / 170507-0 shows no anomaly during the control process.The quality product laboratory observed control charts for five (5) internal samples for six (6) lots of vidas® toxo igm including lots 170306-0, 161202-0 and 170507-0: all of the results were within expected ranges and all batches were within the trend of the parameter.The quality product laboratory tested the control ctcb toxo 163 and found an equivocal result on vidas® toxo igm lot 161202-0.The results indicated in the ctcb report were confirmed.Complementary results are indicated in ctcb report for control ctcb toxo 163: -vidas® toxo igg ii: 95 ui/ml positive (pre-testing result), -vidas® toxo avidity: 0410 tv high (pre-testing result), -toxo isaga positive (result found by 12/12 participants).A result of avidity higher than 0.300 indicates an old infection, older than 4 months.Conclusion: probable old infection for control ctcb toxo 163.This control could contain residual igm, which are not detected by the vidas® technique.In the case of a sample from a patient, it is recommended to collect a second sample, 3 weeks after the first collection, to check the kinetics of igg and confirm the avidity result.This conclusion is aligned with the conclusion proposed by the ctcb in the report.Vidas® toxo igm lots 1004881890 / 170306-0, 1004702590 / 161202-0 et 1005939820 / 170507-0 are in the expected performances.Anomaly linked to the control ctcb toxo 163, which probably contains residual igm.

• Brand Name: VIDAS® TOXO IGM
• Type of Device: VIDAS® TOXO IGM
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer Contact: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 6145775
• MDR Text Key: 61506007
• Report Number: 3002769706-2016-00495
• Device Sequence Number: 1
• Product Code: LYR
• 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,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2017
• Device Catalogue Number: 30202
• Device Lot Number: 1004881890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1