MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS RUB IGG II 60 TESTS; VIDAS RUB IGG II 60 TESTS - 30221

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 from (b)(6) reported to biomérieux that they observed a false positive result for a patient tested with vidas rub igg ii 60 tests (ref.30221, lot 1007673260, expiry date = 10-oct-2020).The concerned patient is a pregnant woman, who gave birth on 03-mar-2020.It is reported that this patient did not have neither vaccination, neither gamma-globulin injection.The customer obtained the following results for this patient with vidas rub igg ii 60 tests, lot 1007673260.Test performed on (b)(6) 2020 for a first sample collected before delivery (sample 1): negative.Test performed on (b)(6) 2020 for a second sample collected on (b)(6) 2020 (sample 2): result = 59 iu / ml (positive).Re-tests of both samples performed on (b)(6) 2020: results = 9 iu / ml and 8 iu / ml (negative).Re-test of sample 2 on (b)(6) 2020: result = 7 iu / ml (negative).There is no indication or report from the laboratory that the false positive result led to any adverse event related to the patient's state of health.Ref 30221 is not registered with the fda for use in the united states.According to trackit, the registration status for ref 30221 is "on hold." however, a similar product, ref 30226, is registered with the fda for use in the united states (k141133).A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An investigation was initiated in response to a customer complaint of a false positive result for a patient tested with vidas rub igg ii 60 tests (ref.30221, lot 1007673260, expiry date = 10-oct-2020).The complaints laboratory performed a historical review of complaint records for the period between the 19mar2019 and the 28may2020.The review identified one (1) other complaint for false positive result, but the cause for the false positive result was the presence of an interference.The analysis of vidas rub igg ii lot 1007673260 /201010-0 showed no anomaly during the manufacturing, control and packaging processes.The instrument logs and one (1) sample (512200650166) were received from the customer for investigational purposes.Control chart analysis: this analysis was performed with four (4) internal negative samples on five (5) vidas® rub igg ii lots, including the customer's lot (1007673260 /201010-0).All samples tested on all lots obtained negative results and the customer's lot was in trend with the other lots.Customer sample: the customer's sample was tested with a retain sample of the customer's lot (1007673260 /201010-0).Analysis was performed on a vidas® 3 instrument twice and on a vidas® pc instrument twice.Negative results were obtained three (3) times and an equivocal result was obtained one (1) time.The variability observed during these tests is in accordance with expected variation for negative results.The customer's false positive result was not reproduced internally.Analysis performed by the system engineering and support department: the instrument logs collected on the customer¿s vidas®3 instrument were analyzed internally and did not highlight any anomalies.Conclusion: the customer's false positive result was not reproduced internally.According to the analysis performed on the instrument logs, there was no anomaly identified that could cause the false positive result.A potential cause for the false positive result observed by the customer is the presence of interference in the sample that has dissipated over time.

• Brand Name: VIDAS RUB IGG II 60 TESTS
• Type of Device: VIDAS RUB IGG II 60 TESTS - 30221
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR
• MDR Report Key: 9924428
• MDR Text Key: 207754978
• Report Number: 8020790-2020-00040
• 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: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2020
• Device Catalogue Number: 30221
• Device Lot Number: 1007673260
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/13/2020
• Initial Date FDA Received: 04/03/2020
• Supplement Dates Manufacturer Received: 05/29/2020
• Supplement Dates FDA Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1