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 Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer in (b)(6) reported false negative result when testing qc sample with vidas® sars-cov-2 igm (9com) 60t ref.423833 lot 1008333260.The concerned external qc sample was veq program sierologia sars-cov 2 - 2020 sample 3.The expected result was positive, but the result obtained by the customer was negative (0.98).Interpretation of results according to test value (i) is as follows: index interpretation: i < 1.00 negative, i = 1.00 positive.There is no patient associated with this external qc isolate; therefore, there is no adverse event related to any 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

A customer in (b)(6) notified biomérieux of obtaining false negative results when testing an external quality control sample with vidas sars cov-2 igm (ref.423833; lot# 1008333260 / 210924-0).Investigations: the customer stated that none of their quality control sample was available to submit to the biomérieux complaints laboratory for evaluation.No other complaints of false negative results have been reported against the lot in question.Review of the batch history and quality control records did not show any anomalies during the manufacturing, control, or packaging processes.Additionally, no non-conformities or capas are linked to the customer¿s complaint.Testing: study of internal samples control charts: control chart analysis was carried out using 6 internal plasmas with two negative targets and four positive (0.16, 0.34, 1.23, 1.56, 1.71, and 2.51) and 5 lots (including the lot reported by the customer).All the samples gave results within their acceptable ranges.Tests performed by the complaints laboratory.Three internal, positive samples (targets 1.56, 1.71, and 2.51) were tested on kits retained from the production of the customer¿s lot.All results were within specifications and no significant differences were observed as compared to the results obtained before the batch release.Conclusion: the complaints laboratory is unable to investigate this issue further, as they do not have access to the quality control sample used by the customer.They were unable to reproduce or confirm the issue reported and the vidas sars cov-2 igm lot is working within specifications.The details regarding the customer¿s quality control sample are not known (pool of sera, diluted positive sample, spice sample, etc¿).Quality control samples are not identical to patient samples and manufacturing process can affect the sample matrix and control results.The clsi guideline ep14-a3 state that processed samples used as quality control material can have a matrix effect: ¿current scientific data suggest that such use of pt / eqa results is not always feasible because of matrix effects.These processed materials us as pt / eqa samples sometimes do not behave like patient samples routinely analyzed in the laboratory.Biases not generally seen with fresh biological fluids, are frequently seen with pt / eqa samples.¿ there have been no other complaints for a false negative result on vidas sars cov-2 igm batch 1008333260.

• 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
• Manufacturer (Section G): BIOMERIEUX SA; 376 chemin de l orme; marcy l'etoile 69280 ; FR 69280
• Manufacturer Contact: jennifer schmatz ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 11096261
• MDR Text Key: 250338235
• Report Number: 8020790-2020-00146
• 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: 03/05/2021

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: 09/24/2021
• Device Catalogue Number: 423833
• Device Lot Number: 1008333260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1