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 in (b)(6) notified biomérieux that they observed a false positive result for a patient tested with vidas® rub igg ii 60 tests (ref 30221, lot 1007944810).The customer stated that the positive result was not consistent with the patient's history, as all previous tests obtained negative results.Sample id (b)(6) initial: 88 iu/ml (positive) the customer performed testing in parallel for the sample collected on (b)(6) 2020 (sample id (b)(6)) and on a previous sample, collected on (b)(6) 2020 (sample id (b)(6)) with the implicated lot of vidas® rub igg ii 60 tests as well as a second lot 1007944810 ).All additional testing obtained negative results.017662116 with lot 1007944810: on (b)(6) 2020 at 14:42, the result was 1 iu/ml (negative) (b)(6) with lot 1007944810: on (b)(6) 2020 at 14:49, the result was 0 iu/ml (negative).(b)(6) with lot 1007944810: on (b)(6) 2020 at 15:32, the result was 0 iu/ml (negative).(b)(6) with lot 1008034500: on (b)(6) 2020 at 10:47, the result was 0 iu/ml (negative).(b)(6) with lot 1008034500: on (b)(6) 2020 at 10:47, the result was 0 iu/ml (negative).There is no indication or report from the customer that this event led to any adverse event related to the patient's state of health.A biomérieux internal investigation has been initiated.Note: reference 30221 is not registered in the united states.The u.S.Similar device is product reference 30226.

Manufacturer Narrative

This report was initially submitted following notification from a customer in italy regarding a false positive result for a patient tested with vidas® rub igg ii 60 tests (ref (b)(4), lot 1007944810).The customer stated that the positive result was not consistent with the patient's history, as all previous tests obtained negative results.The customer returned three (3) unopened boxes of vidas® rub igg ii 60 tests lot 1007944810/210303-0 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 1007944810/210303-0.The complaint laboratory reviewed 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 1007944810/210303-0.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.The ml2 logs analysis by support showed there were no instrument issues associated with the customer¿s lot.In addition, the validation-method-support department did not reproduce the customer¿s positive result when testing ninety (90) times on an internal negative sample on the customer's returned kits.Without the customer's return sample, biomerieux cannot pursue further investigation.The root cause has not been identified.According to the investigation, vidas® rubg ii ref 30221 lot 1007944810 / 210303-0 is still within expected performance.See section h10.

• 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: 10649068
• MDR Text Key: 230493133
• Report Number: 8020790-2020-00108
• 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: 03/23/2021

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: 03/03/2021
• Device Catalogue Number: 30221
• Device Lot Number: 1007944810
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 10/08/2020
• Supplement Dates Manufacturer Received: 03/03/2021
• Supplement Dates FDA Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1