MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS SARS-COV-2 IGG; VIDAS® SARS-COV-2 IGG

Catalog Number 423834

Device Problem False Negative Result (1225)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of obtaining a false negative result for a patient¿s sample when using vidas® sars-cov-2 igg (9cog) 60t (ref.423834, lot 1008142160 expiry 11 jun 2021) on their minividas instrument, serial number (b)(4).The customer reported that they observed a false negative vidas sars-cov-2 igg result with one patient sample in comparison with another method, roche, eclia, sars-cov-2 ab (polyvalent, iga, igm and igg).The customer performed their last calibration on (b)(6) 2020 and it was valid as follows : s1 : 152 rfv(mean) - mle range (s1 : 86 ¿ 186 rfv).C1: 3.24 result positive ¿ mle range (c1: 1.90 - 5.00).C2: -0.03 result negative.The customer reported that they obtained on (b)(6) 2020 the following result on the patient sample : 0.89 result negative.There is no indication or report from the customer that this incident have led to any adverse event related to the patient's state of health.A biomérieux internal investigation has been initiated.Note: reference 423834 is not sold or distributed in the united states.However, u.S-only product reference, 423834-01, has the same formulation and physical properties as reference 423834.

Manufacturer Narrative

This report was initially submitted following notification from a customer in (b)(6) regarding a false negative result for a patient¿s sample when using vidas® sars-cov-2 igg (9cog) 60t (ref.423834, lot 1008142160, expiry 11jun2021) on their minividas serial number (b)(4).The patient sample was not available for submission to perform investigational testing.No anomalies were identified during the manufacturing, quality control, and packaging processes on vidas® sars-cov-2 igg (9cog) 60t (ref.423834, lot 1008142160).The control cards analysis of four (4) internal samples showed that the customer's lot conformed to the specifications, and was in the trend of the other lots.The complaints laboratory tested three (3) positive internal samples and one (1) negative internal sample on the retain kit of the customer¿s lot.The sample results complied with the expected specifications.The customer¿s false negative result was not reproduced by the complaints lab.Without the patient sample, it is not possible to pursue further investigation and explain the result observed by the customer.Per the investigation, vidas® sars-cov-2 igg ref.423834 lot 1008142160 / 210611-0 is still within specifications.

• Brand Name: VIDAS SARS-COV-2 IGG
• Type of Device: VIDAS® SARS-COV-2 IGG
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX SA; chemin de l orme; marcy l etoile 69280 ; FR 69280
• Manufacturer Contact: tenika rhodes ; 100 rodolphe street; durham, NC 27712
• MDR Report Key: 11087427
• MDR Text Key: 252299130
• Report Number: 8020790-2020-00142
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: UNCLASSIFIED
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2021
• Device Catalogue Number: 423834
• Device Lot Number: 1008142160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1