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 of false negative rubella igg results when testing a patient¿s sample with vidas® rub igg ii 60 tests (ref 30221, lot 1007754110) on mini-vidas® instrument.On (b)(6) 2020, calibration of the new kit of vidas rub igg lot 1007754110 was performed and passed.At this time, the initial patient sample (serum) was tested, and result was negative.Id 110 (serum) = 0 iu / ml - negative (bdf = 179; rfv = -3).On (b)(6) 2020, a second serum sample and a plasma sample from the same patient were tested and both obtained positive results.A frozen aliquot of the patient's initial serum sample (previously tested on (b)(6) 2020) was also tested and obtained a positive result.Id 376 (serum) = 136 iu / ml - positive (bdf = 188; rfv = 2522); id 376 (plasma) = 153 iu / ml - positive (bdf = 190; rfv = 2688); repeat of id 110 (serum) = 144 iu / ml - positive (bdf = 188; rfv = 2599).Due to the low rfv (relative fluorescence value) obtained during initial testing, it is suspected that there was a lack of patient sample during the initial test.The customer stated that the initial negative result obtained during the initial test was reported to the physician.However, there is no indication or report from the customer that the false negative result led to any adverse event related to the patient's state of health.It was specified that the customer has not been performing weekly qcv tests.A qcv kit was provided to the customer and the customer performed qcv testing.The qcv testing was in conformance with specifications.Ref 30221 is not registered with the fda for use in the united states.However, a similar product, ref 30226, is registered with the fda for use in the united states (k141133).A biomérieux internal investigation has been initiated.

Manufacturer Narrative

An investigation was initiated in response to a customer complaint of false negative rubella igg results when testing a patient¿s sample with vidas® rub igg ii 60 tests (ref 30221, lot 1007754110) on mini-vidas® instrument.The customer did not submit the sample for investigational testing.All investigational testing was performed with biomérieux internal samples.A review of complaints registered for vidas® rub igg ii 60 tests (ref 30221, lot 1007754110) did not identify any other complaints against this lot for the same issue.The quality control data for this lot was also reviewed and the lot met release criteria.There were no anomalies identified for this lot during manufacturing, control, and packaging processes.Control chart analysis was performed as part of the investigation.The analysis was performed on six (6) internal samples on six (6) vidas rub igg ii lots including the customer¿s lot.All the samples gave results in accordance with their acceptable ranges and customer¿s lot is in the trend with the other lots.The complaints laboratory tested four (4) internal samples with known igg values (4, 11, 31, and 169 iu/ml) using retains of the customer's lot.These samples are used for the activity panel performed prior to batch release.All results were within specification and were similar to results obtained before batch release, indicating there has been no evolution of the product performance over time.To simulate pre-analytical handling errors, the complaints laboratory also performed two (2) tests with a retain kit from the customer's lot where one assay was performed without sample added to the strips and the other without spr (solid phase receptacle).The results were negative (0 iu/ml) with rfv of -1 and -2.These results are similar to those obtained by the customer during the customer's initial assay.The investigation concluded that the likely cause for the customer's negative result during the initial assay is a user error during the pre-analytical step.The product vidas rub igg ii lot 1007754110/201118-0 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: 10398441
• MDR Text Key: 242628828
• Report Number: 8020790-2020-00073
• 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: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2020
• Device Catalogue Number: 30221
• Device Lot Number: 1007754110
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1