MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS RUB IGG II; VIDAS® RUB IGG II

Catalog Number 30221

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 from (b)(6) notified biomérieux of obtaining a false negative result for a pregnant patient in association with vidas® rubella igg ii assay (ref.30221, lot 1007596330) at position a2.The sample was separated into two vials, one stored frozen and one stored at 2-8°c.Both samples were tested a second sample was also obtained, the second sample was tested twice a summary of all the patient results is listed below.Sample 1 initial test: result = 5 iu/ml (negative).Sample 1 re-test 2-8°: result=18 iu/ml (positive).Sample 1 re-test frozen: result=20 iu/ml (positive).Sample 2 initial test: result =17 iu/ml (positive).Sample 2 re-test: result =16 iu/ml (positive).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.A biomérieux internal investigation will be initiated.Note: product reference (b)(4) is not sold or distributed in the united states.However, similar device product reference (b)(4) is marketed in the united states.

Manufacturer Narrative

This report was initially submitted following notification from a customer in france regarding a false negative result for a pregnant patient in association with vidas® rubella igg ii assay (ref.30221, lot 1007596330) at position a2.Quality control records: the analysis of vidas rub igg ii lot 1007596330 / 200903-0 showed no anomaly during the manufacturing, control and packaging processes.Control chart analysis: the analysis was performed on four internal samples from the quality control panel (two positive and two negative samples).This analysis was carried out on 6 vidas rub igg ii batches including the customer¿s lot (1007596330 / 200903-0).All of the samples gave results in accordance with the expected interpretation.Tests performed by the complaints laboratory: the patient¿s sample was returned by the customer to biomerieux.The complaints laboratory tested it 10 times on a vidas 3 (manual pipetting because of the volume received).A positive interpretation was systematically observed.The laboratory did not reproduce the isolated negative result observed by the customer.Instrument investigation: the instrument logs collected on the customer¿s vidas3 instrument revealed a section pump pressure drop was noted on 20-dec-2019 (date of event) due to a small leakage.The pressure was low but not enough to be out of the specifications and set off an alarm.This may be due to a foreign object on the seal.The object may have been suppressed after a spr unload or a cleaning by the customer.Root cause: section pump pressure drop due to a small leakage.

• Brand Name: VIDAS RUB IGG II
• Type of Device: VIDAS® RUB IGG II
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile 69280 ; FR 69280
• MDR Report Key: 9713510
• MDR Text Key: 204775876
• Report Number: 8020790-2020-00018
• Device Sequence Number: 1
• Product Code: LFX
• Combination Product (y/n): N
• PMA/PMN Number: K141133
• 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: 04/29/2020

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: 09/03/2020
• Device Catalogue Number: 30221
• Device Lot Number: 1007596330
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/16/2020
• Initial Date FDA Received: 02/14/2020
• Supplement Dates Manufacturer Received: 04/06/2020
• Supplement Dates FDA Received: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1