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 eqa toxo 163, in association with the vidas® toxo igm test.The customer indicated the serum is a known positive and the test results were: 0.49 => negative.An internal biomérieux investigation was conducted.The complaint is about the (b)(6) eqa toxo 163 from ctcb (centre toulousain pour le contrôle de qualité en biologie clinique) found negative by the majority of participants whereas it was expected to be positive with vidas® toxo igm reference (b)(4).Results for this control ctcb toxo 163 are as follows : (b)(6) participants gave a positive result as expected, (b)(6) participants gave an equivocal result, (b)(6) participants gave a negative result.The study of batch history record for vidas® toxo igm lots 1004881890 / 170306-0 shows no anomaly during the control process.The quality product laboratory observed control charts for 5 internal samples from quality control department for 6 lots of vidas® toxo igm.All the results are within expected ranges and all batches are within the trend of the parameter.Quality product department tested the control ctcb toxo 163 and found an equivocal result on a different vidas® toxo igm lot.Quality product department confirms results indicated in ctcb report.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 igg avidity : 0410 tv high (pre-testing result), toxo isaga positive (result found by 12/12 participants).An result of avidity higher than 0.300 indicates an old infection, older than 4 months.Quality product conclude to a probable old infection for control ctcb toxo 163.This control could contain residual igm which are not detected by vidas® technique.This conclusion matches with the conclusion proposed by the ctcb in the report.Vidas® toxo igm lots1004881890 / 170306-0 performed as expected.An anomaly was 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: 6177580
• MDR Text Key: 62692691
• Report Number: 3002769706-2016-00514
• 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
• Report Date: 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• 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: 11/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1