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 in (b)(6) notified biomérieux of discrepant results associated with vidas® toxo igm.The customer reported that they obtained a false negative result.Eqa ctcb 1711 was first obtained at 0.69 (positive result) (465 rfv) and was retested by the customer after centrifugation and the result obtained was 0.63 (equivocal result)(424 rfv).The result of 0.63 was transmitted to the ctcb.There is no patient associated with this test result because the testing was part of eeq ctcb.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

A customer in france notified biomérieux of a false negative result for an eqa ctcb 1711 sample associated with vidas® toxo igm.An investigation was performed.The report from ctcb ( centre toulousain pour le contrôle de qualité en biologie clinique - eqa french provider) was reviewed, whereas, ctcb toxo 171 - sample 1711, was found negative by three participants when it was expected to be positive with vidas® toxo igm (reference (b)(4)).Results for ctcb toxo 171 - sample 1711 were as follows : 75 participants gave a positive result as expected, 24 participants gave an equivocal result, 3 participants gave a negative result.A review of quality records confirmed the manufacturing of vidas® toxo igm lots, 170608-0 / 171213-0 / 180213-0 and 170718-0, were within specification.The ctcb toxo 171 sample 1711 was tested and the result was positive on vidas® toxo igm lots 170608-0, 171213-0 and lot 180213-0.A complementary avidity test was performed for the external quality control ctcb toxo 171 sample 1711, and gave a high avidity result.According to the package insert, a result of avidity higher than 0.300 indicates an old infection, older than 4 months.The conclusion of a probable old infection for external quality controls ctcb toxo 171 samples 1712, is coherent with the age of pregnancy indicated in ctcb report (10 weeks for sample 1711).Hypothetis : 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.It is acceptable to obtain a doubtful result in a context of old infection, especially more than the sensitivity is higher than 90% in the context of a recent infection (cnr publication - j.Clin.Microbiol.-2016-villard-3034-42).The external quality controls are composed of human matrix.Eqa are manufactured and cannot be considered as natural samples from patient.In conclusion, there is no performance issue and vidas® toxo igm performed as expected.

• 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
• Manufacturer (Section G): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280; FR
• Manufacturer Contact: ellen weltmer ; 595 anglum road; saint louis, MO 63042
• MDR Report Key: 6644879
• MDR Text Key: 77842979
• Report Number: 3002769706-2017-00138
• 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,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2017
• Device Model Number: 30202
• Device Lot Number: 1005385420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1