MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS TOXO IGG AVIDITY TESTS; VIDAS® TOXO IGG AVIDITY TESTS

Catalog Number 30222

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of obtaining false high igg avidity index result for a pregnant patient in association with the vidas® toxo igg avidity 30tests (ref.30222, lot 1007856750).The customer confirmed the patient had a medical history of negative toxoplasmosis serology; the high igg avidity index was obtained during the seroconversion step.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.Biomérieux has initiated an internal investigation.Reference (b)(4) is not registered in the united states.The u.S.Similar device is product reference (b)(4).

Manufacturer Narrative

A customer in france notified biomérieux of obtaining false high igg avidity index results for two (2) pregnant patients in association with the vidas® toxo igg avidity 30 tests (ref.(b)(4), lot 1007856750).In response to the customer complaint, biomerieux conducted an internal investigation.The customer returned sample was tested in duplicate using the customer lot and a random lot; all results obtained either an intermediate or high avidity level.This indicated the result obtained for customer¿s sample is not linked to a specific batch of vidas toxo igg avidity.The vidas® toxo igg avidity 30 tests ref.(b)(4).Package insert states ¿interference may be encountered with certain sera containing antibodies directed against reagent components.For this reason, assay results should be interpreted taking into consideration the patient history, and the results of any other tests performed.Review of the manufacturing and quality control records found no anomalies during manufacturing.Lot 1007856750 met all quality control release criteria.Analysis of the control cards of six (6) internal sera showed lot 1007856750 is on trend with other vidas® toxo igg avidity 30test lots.Complaint trending analysis was performed from (b)(6) 2019 to (b)(6) 2020, and showed no recurrence of customer¿s issue with lot 1007856750/210103-0.The root cause was not determined.The false high avidity level obtained by the customer was reproduced; however, the result obtained for customer¿s sample is not linked to a specific batch of vidas toxo igg avidity.The investigation determined lot 1007856750 is performing as intended.Refer to section h10.

• Brand Name: VIDAS TOXO IGG AVIDITY TESTS
• Type of Device: VIDAS® TOXO IGG AVIDITY TESTS
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile 69280 ; FR 69280
• MDR Report Key: 10144584
• MDR Text Key: 202812345
• Report Number: 8020790-2020-00045
• Device Sequence Number: 1
• Product Code: LGD
• Combination Product (y/n): N
• PMA/PMN Number: K101946
• 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: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2021
• Device Catalogue Number: 30222
• Device Lot Number: 1007856750
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/14/2020
• Initial Date FDA Received: 06/11/2020
• Supplement Dates Manufacturer Received: 10/07/2020
• Supplement Dates FDA Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1