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

Catalog Number 423833

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Note: reference 423833 is not sold or distributed in the united states.The u.S.Similar device is product reference 423833-01.A customer in italy notified biomérieux of false positive results in association with the vidas® sars-cov-2 igm test kit (ref.423833, batch 1008195280) when testing a serum sample from a (b)(6) year-old female patient.The customer stated the patient presented with allergic asthma and bronchial hyper reactivity and with a family medical history of connective tissue disease and renal neoplasia, and no known exposure to the sars-cov-2 virus.The patient¿s serum sample was tested three (3) times using the vidas® sars-cov-2 igm test kit, vidas® sars-cov-2 igg test kit, and the pcr test method.Results are listed below: results from initial test: sars cov2 igm result = 3.79, positive interpretation.Sars cov2 igg result = -0.04, negative interpretation.Pcr result = 0.2, negative interpretation.Results from second test: sars cov2 igm result = 2.87, positive interpretation.Sars cov2 igg result = -0.03, negative interpretation.Pcr result = 0.3, negative interpretation.Results from third test: sars cov2 igm result = 2.79, positive interpretation.Sars cov2 igg result = -0.03, negative interpretation.Pcr result = 0.1, negative interpretation.The customer confirmed the false positive sars cov2 igm results had no adverse impact on the patient¿s state of health.Biomérieux has initiated an internal investigation.

Manufacturer Narrative

This report was initially submitted following notification from a customer in italy regarding of false positive results in association with the vidas® sars-cov-2 igm test kit (ref.423833, batch 1008195280) when testing a serum sample from a 29-year-old female patient.Three (3) samples from the same patient gave positive results with vidas® sars cov-2 igm batch 1008195280 / 210710-0, while pcr and vidas® sars cov-2 igg results were negative.An analysis of the batch history record of vidas® sars cov-2 igm lot 1008195280/ 210710-0 showed no anomalies during the manufacturing, quality control, and packaging processes.No non-conformity nor capa linked to the customer's complaint recorded on the subject lot.The complaints laboratory performed several tests.The customer¿s sample was not available; however, biomerieux conducted testing using internal samples.Analysis of control charts was performed on seven (7) vidas® sars cov-2 igm batches including the batch used by the customer (1008195280 / 210710-0).All the results were in accordance with the expected specifications, and batch 1008195280 / 210710-0 was in the trend of the other lots.Three (3) samples from the activity panel were tested on the retain of lot 1008195280 / 210710-0.The results complied with the standards, and were close to those obtained during the batch control (no drift since the batch was released).The complaints laboratory tested 20 internal samples (10 plasma and 10 serums) taken before the health crisis linked to covid 19 on the subject lot.All results were negative with test values between 0.07 and 0.63.In conclusion, biomerieux did not reproduce the vidas® sars cov-2 igm positive result of the customer complaint.All complaints laboratory testing gave a negative interpretation.Without the customer's sample biomerieux cannot further investigate on the potential interference.The positive result could be due to the an interference such as but not limited to, rheumatoid factor or anti-nuclear antibody.The package insert of vidas® sars cov-2 igm assay at section limitations of the method states the following: "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." based on the investigation, vidas® sars cov-2 igm ref.423833 batch 1008195280 / 210710-0 is performing as intended.See section h10.

• Brand Name: VIDAS SARS-COV-2 IGM
• Type of Device: VIDAS® SARS-COV-2 IGM
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile 69280 ; FR 69280
• MDR Report Key: 10693685
• MDR Text Key: 246422508
• Report Number: 8020790-2020-00110
• 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: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2021
• Device Catalogue Number: 423833
• Device Lot Number: 1008195280
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1