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

Catalog Number 423834

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

On (b)(6) 2021, a customer in (b)(6) reported to biomerieux that they observed a reproducibility issue leading to false negative results for a patient¿s sample when using vidas sars-cov-2 igg (9cog) 60t (ref.423834, lot 1008326330 expiry 28 jul 2021) on their vidas serial number (b)(4).The customer reported the following situation that occurred at his laboratory: the patient concerned has had covid19 (pathology diagnosed by a positive nasopharyngeal swab).After he obtained the nasopharyngeal swab negative, the patient asked for a serological test in the laboratory.The first serological test was performed on (b)(6) 2020 in the laboratory and the customer reported that they obtained the following results : igg batch 1008326330: positive: result 1.45.Igm batch 1008333260: negative result : 0.85.On (b)(6) 2021, the customer again performed the search for antibodies on the same patient with fresh sample tested twice, with the batches used in (b)(6), and obtaining the following results : igg batch 1008326330: negative results 0.67 - 0.70.Igm batch 1008333260: positive results 1.32 - 1.28.There was a discrepancy between the results obtained in (b)(6) for the two kits.The customer then repeated the tests with different lots of both kits.The results obtained were as follows: igg batch 1008366980: positive 1.02.Igm batch 1008354390 : positive 1.8.The customer reported that they expected a positive result with vidas sars-cov-2 igg.There is no indication or report from the laboratory or physician that this incident led to any adverse event related to the patient's state of health.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.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

This report was initially submitted following notification from a customer in (b)(6) that observed a reproducibility issue leading to false negative results for a patient¿s sample when using vidas® sars-cov-2 igg (9cog) 60t (ref.423834, lot 1008326330 expiry 28 jul 2021) on their vidas® serial number ivd7005074.The patient concerned has had covid19 (pathology diagnosed by a positive nasopharyngeal swab).The customer obtained a positive result for the initial test with lot 1008326330, and negative result on the repeat test.The customer reported that they expected a positive result with vidas® sars-cov-2 igg.The customer¿s sample was requested and returned by the customer for the investigation.Analysis of batch history records showed no anomalies found in the quality monitoring during manufacture, control and packaging.An analysis of internal samples control charts was performed on four (4) positive sera on seven (7) lots of vidas® sars cov igg including that of the customer.All values are within specifications and the customer¿s lot is within the trend of the other lots.The complaint laboratory tested four internal samples (3 with positive targets and 1 negative) on vidas® sars cov-2 igg batch 1008326330/210728-0.All results were within their expected specifications and similar to those observed before the batch release.The complaint laboratory tested the patient sample on the retain kit of the customer¿s lot (1008326330/210728-0), and on another lot of (vidas® sars cov-2 igg (1008366980/210928-0).The sample gave a negative result with an index of 0.95 tv on lot 1008326330/210728-0 and a positive one with an index of 1.10 tv with the lot 1008366980/210928-0.The patient¿s sample was tested with a competitor¿s method using euro immun kit (based on detection of antibodies against the whole spike protein).The sample gave a positive interpretation with antisars-cov-2 elisa igg.The patient¿s sample was also tested using an in-house western blot using the same main raw materials as those used in the manufacturing of vidas® sars cov-2 igg assay (rbd antigen and conjugate).A test was also added using a nucleocapsid antigen instead of rbd protein.The sample results showed the following: a specific band against nucleocapsid antigen when revealing with an igg conjugate.A specific band against rbd protein when revealing with an igg conjugate.However the immune-reactivity against the rbd protein is weak close to the one observed with negative sample with high index (0.97 tv), so it is close to the positive threshold of vidas® sars cov-2 igg assay.According to the investigation, the non-reproducible negative result observed on vidas® sars cov-2 igg with the lot 1008326330/210728-0 can be due to the combination of two root causes: presence of a level of igg antibodies against rbd protein close the positive threshold of vidas® sars cov-2 igg assay leading to a distribution into both sides of the cut-off.The level of s1 obtained during one of the calibrations which was slightly too high even if the result was within the acceptable range.This signal led to a decrease of the index of the sample.In accordance to the investigation, vidas® sars cov-2 igg batch 1008326330/210728-0 is within the expected performance.

• Brand Name: VIDAS SARS-COV-2 IGG
• Type of Device: VIDAS® SARS-COV-2 IGG
• Manufacturer (Section D): BIOMERIEUX SA; 376 chemin de l'orme; marcy l¿etoile 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX SA; 376 chemin de l'orme; marcy l'etoile 69280 ; FR 69280
• Manufacturer Contact: mary mcdonald ; 100 rodolphe street; durham, NC 27712
• MDR Report Key: 11318272
• MDR Text Key: 269876515
• Report Number: 8020790-2021-00010
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2021
• Device Catalogue Number: 423834
• Device Lot Number: 1008326330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1