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

A customer in (b)(6) notified biomérieux of obtaining a false positive result for a patient sample when using vidas® sars-cov-2 igm (9com) 60t (ref.423833, lot 1008356180, expiry date: 01-oct-2021) on their vidas® instrument serial number (b)(4).The customer obtained the following results for a patient¿s sample with vidas sars-cov-2 igm (9com) 60t, lot 1008356180: initial testing on (b)(6) 2020: 5.31 (positive).Re-testing on (b)(6) 2020: 5.00 (positive).The results obtained from two other laboratories for this same patient¿s sample were negative: on (b)(6) 2020 (euroimmune assay): igm= 0.13, cut off 0.8 (negative).On (b)(6) 2021, with chorus sars-cov-2 igm: igm = 0.5 cut off 0.9 (negative).To be noted, all testing was performed from one sample collection.The customer reported that the patient did not have clinical signs of covid-19.The patient had been hospitalized from (b)(6) 2020 to (b)(6) 2020, the result of a ct scan was negative for pulmonary signs of covid-19 and two pcr tests performed were also negative.According to the hospital report, the patient had bacterial pneumonia.There is no indication or report from the laboratory that the discrepant results led to any adverse event related to the patient's state of health.It is noted that the results were reported to the patient.A biomérieux internal investigation has been initiated.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 a false positive result for a patient sample when using vidas® sars-cov-2 igm (9com) 60t (ref.423833, lot 1008356180, expiry date: 01-oct-2021) on their vidas® instrument (serial number (b)(6) ).The results obtained from two other laboratories for this same patient¿s sample were negative.The customer¿s sample was not available for testing for the investigation.The analysis of the batch history records of vidas® sars cov-2 igm batch 1008356180 / 211001-0 showed no anomalies during the manufacturing, quality control, and packaging processes.Three (3) internal samples with the targets close to the cut off at 0.75, 1.71, and 2.51 test values were tested on the retain kit of vidas® sars cov-2 igm batch 1008356180 / 211001-0.No deviations were observed from the lot since its release.Five (5) samples collected before the pandemic (so expected negative) were also tested on the retain kit of vidas® sars cov-2 igm batch 1008356180 / 211001-0.All the samples gave a negative result.The investigation did not reproduce the vidas® sars cov-2 igm positive result obtained by the customer.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, anti-nuclear antibody).The package insert of vidas® sars cov-2 igm assay states the following 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." according to the information mentioned above, there is no reconsideration of the performance for vidas® sars cov-2 igm ref.423833 batch 1008356180 / 211001-0.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: 11331756
• MDR Text Key: 239752776
• Report Number: 8020790-2021-00012
• 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: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2021
• Device Catalogue Number: 423833
• Device Lot Number: 1008356180
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1