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

Note: reference 30221 is not registered in the united states.The u.S.Similar device is product reference 30226.A customer in (b)(6) notified biomérieux of potential false positive results in association with the vidas® rbgii test kit (ref.30221, lot 1008034500) when testing a patient sample on their vidas® 3 instrument (serial number (b)(4)).The customer tested the patient sample twice using lot 1008034500 and obtained results of 45 iu/ml positive and 40iu/ml positive.The customer confirmed the expected result was negative, as the patient¿s previous results were negative.Sample from (b)(6) 2020: results on rbg 2 ui/ml negative and rbm 0.17 negative.Sample from (b)(6) 2020: results on rbg 2 ui/ml negative and rbm 0.13 negative.Sample from (b)(6) 2020: results on rbg 4 ui/ml negative and rbm 0.12 negative.The most recent calibration was performed on (b)(6) 2020 and was in conformance with specifications.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 will initiate an internal investigation.

Manufacturer Narrative

This report was initially submitted following notification from a customer in italy regarding potential false positive results in association with the vidas® rbgii test kit (ref.(b)(4), lot 1008034500) when testing a patient sample on their vidas® 3 instrument (serial number (b)(6)).The customer returned two (2) samples to biomerieux for testing for the investigation.A review of the batch history records showed no anomalies during the manufacturing, quality control, and packaging processes for vidas® rub g ii lot 1008034500/ 210408-0 in connection with the complaint.The complaint laboratory observed six (6) internal samples with different targets, on six (6) different batches of vidas® rub g ii ref (b)(4) including the customer's lot 1008034500/ 210408-0.The analysis of the control charts showed that all results were within specifications, and the customer's lot was in the trend of the other lots.One of the customer¿s samples ((b)(6)) was sent to an external laboratory to be tested on a competitor method.A"negative" result was reported using liaison diasorin.The second sample ((b)(6)) was tested on five (5) vidas® rubgii batches including the customer's lot 1008034500/210408-0.Only the customer's batch (lot 1008034500) showed positive results with the sample; the other lots gave negative results.According to additional testing, the positive results could be due to a nonspecific binding between a substance present in the sample, and a raw material used for the manufacturing of sprs used for vidas® rub g ii lot 1008034500/210408-0.However, the raw material was not available for further investigation to confirm.The following is mentioned in vidas® rub igg ii ref.(b)(4) package insert at the section limitations of the method: ¿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's history, and the results of any other tests performed.¿ according to the investigation, there is no reconsideration of vidas® rubg ii ref (b)(4) lot 1008034500/210408-0 performance.

• 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 69280
• MDR Report Key: 10645258
• MDR Text Key: 230492678
• Report Number: 8020790-2020-00106
• 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: 03/25/2021

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: 04/08/2021
• Device Catalogue Number: 30221
• Device Lot Number: 1008034500
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/07/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 03/11/2021
• Supplement Dates FDA Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1