MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS RUB IGG II 60 TESTS; VIDAS® RUB IGG II 60 TESTS

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 from (b)(6) notified biomérieux of obtaining a false positive result for a patient sample in association with the vidas® rub igg tests (ref.30221, lot 1007944810) tested at position a3 of their vidas® instrument.The customer stated the patient sample, id (b)(6), was tested in twelve (12) compartments of the vidas® 3 instrument and obtained a negative result between 3 and 4 ui/ml for eleven (11) of the tests.One test at positon a3 obtained a positive result of 16 ui/ml.There is no indication or report from the customer that the discrepant result led to any adverse event related to the patient's state of health.Biomérieux has initiated an internal investigation.

Manufacturer Narrative

This report was initially submitted following notification from a customer in luxembourg regarding a false positive result for a patient sample in association with the vidas® rub igg tests (ref.30221, lot 1007944810) tested at position a3 of their vidas® instrument.The customer¿s samples was not returned for the investigation.Four (4) internal samples (2 with a positive target, 1 with an equivocal target and 1 with a negative target) were tested on vidas® 3 instrument with the batch vidas® rubg ii ref.30221 lot 1007944810 / 210303-0.All the results were within acceptable range, and without any evolution over time compared to the results observed before the batch release.A negative sample (target at 3 iu / ml) was tested in repeatability nine (9) times on a vidas® 3 instrument.All the results obtained were negative with values between 2 and 3 iu / ml.Additional repeatability testing was conducted on an internal negative sample tested 90 times on vidas® rub igg ii lot 1007944810 / 210303-0 kits retrieved from the customer's site.All the results observed were negative as expected.There were no anomalies detected in the instrument logs of lot 1007944810 that could explain the positive vidas® rub igg ii result observed on position a3.Without any patient sample available, biomérieux cannot pursue further the investigation.The root cause of the issue could not be identified.There is no reconsideration of the performance of vidas® rubg ii ref.30221 lot 1007944810 / 210303-0.

• Brand Name: VIDAS RUB IGG II 60 TESTS
• Type of Device: VIDAS® RUB IGG II 60 TESTS
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile 69280 ; FR 69280
• MDR Report Key: 10373349
• MDR Text Key: 233892005
• Report Number: 8020790-2020-00071
• Device Sequence Number: 1
• Product Code: LYR
• 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: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2021
• Device Catalogue Number: 30221
• Device Lot Number: 1007944810
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1