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

Catalog Number 30221

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer from (b)(6) notified biomérieux of obtaining a false positve result for a patient known to be negative when testing with the vidas® rubella igg ii assay (ref 30221, lot 1007220320) at position a1.The sample was retested in positons b1 and b2.Results are as follows: initial test at position a1: 626 rfv / 28 iu / ml => positive.Retest at postitions b1 and b2: 57 rfv / 2 iu / ml, 61 rfv / 2 iu / ml.The customer confirmed there was no adverse impact to the patient's state of health due to the false positive result.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation was initiated for a customer report of obtaining a false positive result for a patient known to be negative when testing with the vidas® rubella igg ii assay (ref 30221, lot 1007220320) at position a1.The customer submitted the patient sample for the investigation.The investigation included a review of batch history records, testing of internal samples and the customer's returned patient sample with the customer's lot, and a review of vidas 3 instrument data.The analysis of the batch history records determined there was no anomaly during the manufacturing , control and packaging processes.A study of internal samples control charts was performed.Four internal samples from activity panel were analyzed.This analysis was carried out on all lots of vidas rub igg ii between lot 191210-0 and lot 200724-0 including customer lot: 200313-0.Results were within specifications.The customer's lot is in the trend of the other lots.Internal testing was performed on internal samples (negative and positive sera) and on the returned patient sample (n° 193003781501).The return patient sample as well as four internal sera were tested on vidas 3 in automatic mode on retained kit, vidas rub igg ii batch 1007220320 / 200313-0.The results obtained for the return sample are negative (2 ui/ml).The customer's anomaly was not reproduced internally.All results obtained for the four internal samples are in accordance with their expected specifications the vidas 3 log files analysis showed that there was no issue on the instrument for the vidas rub igg ii assay regarding: · the temperatures of the sections · the section pumps · the scanner head conclusion: the false positive result obtained by the client is an isolated anomaly, not reproduced internally and not explained according to our investigation results.According to the investigation, vidas rub igg ii lot 1007220320 is performing as intended.

• 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, rhone 69280, ; FR
• MDR Report Key: 8984489
• MDR Text Key: 218748961
• Report Number: 8020790-2019-00053
• 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: 10/28/2019

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: 03/13/2020
• Device Catalogue Number: 30221
• Device Lot Number: 1007220320
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/12/2019
• Initial Date FDA Received: 09/10/2019
• Supplement Dates Manufacturer Received: 10/02/2019
• Supplement Dates FDA Received: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1