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

Catalog Number 30221

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer from (b)(6) reported false positive results for a serological external quality control sample, from the eqa qcmd (b)(6) 2017 campaign, in association with the vidas® rub igg ii assay (lot 1005490680).The qcmd testing scenario mentioned, "a stem cell transplant recipient is screened for immunity to several pathogens before transplantation." the vidas rub igg result for sample qcmd4 was positive (15 iu/ml) while the expected result was equivocal.According to qcmd eqa report, participant results were: architect : positive result (30%) and negative result (70%).Vidas : positive result (100%).Siemens : positive result (100%).Diasorin : negative result (more than 60%) equivocal result (20%) and positive result (20%).A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation was performed with results as follows: the analysis of the batch history records of vidas® rub igg ii batch 1005490680/ 180201- 0 showed no anomaly during the manufacturing and control processes.Vidas® rub igg ii batch 1005490680/ 180201-0 was already expired when the complaint was recorded, it was impossible to perform any testing on the concerned batch.However, as biomerieux subscribes to external quality assessment programs, an analysis of the results obtained on ctcb program campaigns of 2016 and 2017(total of 6 challenges) for vidas® rub igg ii was performed.This analysis showed that all the results obtained were compliant to the peer group results and were within specifications.Without any customer quality control (qc) material, it is not possible to further investigate the customer's complaint.The customer obtained for sample 4 a result of 15 ui/ml (corresponding to vidas® rub igg ii cut-off value) and because there is a high variability of the interpretation obtained with different assays (see qcm report 2017-challenge c2); the assumption is that the sample is close to the positivity cut-off.No additional information regarding the way the customer prepared the sample to determine the equivocal status of this quality control material.Moreover, quality control samples are not identical to patient samples, quality control manufacturing process can affect sample matrix and control results.According to the data mentioned above, the batch vidas® rub igg ii batch 1005490680/ 180201-0 is still within the expected specification.

• Brand Name: VIDAS® RUB IGG II
• Type of Device: VIDAS® RUB IGG II
• Manufacturer (Section D): BIOMERIEUX SA; 376, chemin de l'orme; marcy l'etoile, 69280 ; FR 69280
• MDR Report Key: 7349390
• MDR Text Key: 103277207
• Report Number: 3002769706-2018-00044
• Device Sequence Number: 1
• Product Code: LFX
• Combination Product (y/n): N
• PMA/PMN Number: K080766
• 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: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2018
• Device Catalogue Number: 30221
• Device Lot Number: 1005490680
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1