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

Catalog Number 423833

Device Problem False Negative Result (1225)

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

Event Type  malfunction  

Event Description

On the 3rd of december 2020, a customer in (b)(6) reported to biomérieux that they obtained discrepant results (potential false negative result) with the product vidas® sars-cov-2 igm (ref 423833, batch 1008312650, expiry date 13-sep-2021) compared to other methods.The customer stated that a patient sample was repeatedly positive (three times) on swab, even after having spent 14 days of quarantine, he was negative only to the 4th test (on swab) that has been practiced.The results were as follows: abbott: igm result 1 = 1.63 ; igm result 2 = 1.10 : positive interpretation.Roche: ig result = 2.18 : positive interpretation.Vidas: igm result 1 = 0.39 ; igm result 2 = 0.39 ; igm result 3 = 0.45 : negative interpretation.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation has been initiated.Note: reference 423833 is not sold or distributed in the united states.However, u.S-only product reference, 423833-01, has the same formulation and physical properties as reference 423833.

Manufacturer Narrative

This report was initially submitted following notification from a customer in italy regarding discrepant results (potential false negative result) with the product vidas® sars-cov-2 igm (ref (b)(4), batch 1008312650, expiry date 13-sep-2021) compared to other methods.There was no quantity left of the customer¿s sample to be sent to biomerieux for the investigation.The analysis of the batch history records of vidas® sars cov-2 igm batch 1008312650 / 210913-0 showed no anomalies during the manufacturing, quality control, and packaging processes.The complaints laboratory did not reproduce the vidas® sars cov-2 igm negative result with internal samples tested on the retain kit of the customer's lot.The results of the internal samples were within specification ranges and without any observation of interpretation change.The control chart analysis of six (6) internal samples showed the customer's lot, vidas® sars cov-2 igm reference (b)(4) batch 1008312650 / 210913-0, was in the trend of other vidas® batches.All of the samples were in accordance of their acceptable ranges.Without the customer¿s sample return, biomerieux cannot further investigate this issue.According to the investigation, there is no reconsideration of the performance of vidas® sars cov-2 igm ref.(b)(4) batch 1008312650 / 210913-0.It is mentioned in the package insert of vidas® sars cov-2 igm assay at section limitations of the method: "the individual immune response following sars-cov-2 infection varies considerably and might give different results with assays from different manufacturers.Results of assays from different manufacturers should not be used interchangeably." abbott and roche methods do not detect the same target (nucleocapsid) as the vidas® method (rbd subunit of spike).See section h10.

• Brand Name: VIDAS SARS-COV-2 IGM
• Type of Device: VIDAS® SARS-COV-2 IGM
• Manufacturer (Section D): BIOMERIEUX SA; 376 chemin de l'orme; marcy l¿etoile 69280 ; FR 69280
• MDR Report Key: 11096344
• MDR Text Key: 250341096
• Report Number: 8020790-2020-00148
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• PMA/PMN Number: UNCLASSIFIED
• 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: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2021
• Device Catalogue Number: 423833
• Device Lot Number: 1008312650
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1