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

Catalog Number 423833

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

On (b)(6) 2022, a customer from (b)(6) notified biomérieux of obtaining false positive result when testing external quality sample with vidas sars-cov-2 igm (9com) 60t (ref.423833, batch number: 1008982120, expiry date: 14-sep-2022).The customer participated in ukneqas qc program for sars-cov-2/covid-19 antibodies.In the distribution 221, the expected target of the specimen 221-2 was 0.92 with a negative interpretation for immunoassay users.The customer result was i=1.61 which is considered as a positive result with the qualitative assay vidas sars-cov-2 igm (9com) 60t (ref.423833).In the distribution 223 (igm ¿ quantitative), the expected target of the specimen 223-1 was 0.49 with a negative interpretation for immunoassay users.The customer result was i=1.00 which is considered as a positive result with the qualitative assay vidas sars-cov-2 igm (9com) 60t (ref.423833).As there is no patient associated with this external quality control, there is no adverse event related to any patient's state of health.A biomérieux internal investigation will be initiated.Note: reference 423833 is not registered in the united states.The u.S.Similar device is product reference 423833-01.

Manufacturer Narrative

An internal investigation was performed following a notification/complaint from a customer from portugal who obtained a false positive result when testing external quality sample from uk neqas organization (program sars-cov-2/covid 19 ab distributions 221 and 223) with vidas sars-cov-2 igm (9com) 60t (ref.(b)(4), batch number: 1008982120, expiry date: 14-sep-2022) with the following results: an index of 1.61 tv for sample id- (b)(6) while this sample was expected negative.Target value indicated by uk neqas: 0.92 and the sample is intended positive for igg anti sars cov-2.An index of 1.00 tv for sample id- (b)(6) while this sample was expected negative.Target value indicated by uk neqas: 0.49 and the sample is intended positive for igg anti sars cov-2.1) complaint analysis: the complaint analysis did not reveal this issue as a systemic quality issue.2) quality control records: there is neither capa nor non-conformity linked to this issue on this vidas assay.3) analysis and tests conducted by complaints laboratory 3.1) control chart analysis this analysis was carried out: on three (3) internal samples with a respective target at 0.49 / 0.62 and 0.89 tv (positive threshold: 1.00 tv).On six (6) batches of vidas sars cov-2 igm including the customer¿s lot 1008982120.The analysis of the control charts showed that all results are within specifications and the lot mentioned by the customer is in the trend compared to the other lots.3.2) test on internal samples: the complaints laboratory tested 3 internal samples with negative target (indexes between 0.49 and 0.89 tv for a positive threshold of 1.00 tv) on a retain kit of vidas sars cov-2 igm lot 1008982120 (lot mentioned by the customer).The results obtained complied to the specifications and were not significantly different compared to those observed before the batch release.We did not observe any significant evolution over time of vidas sars cov-2 igm lot 1008982120 on these samples.3.3) analysis of reports related to eqa program: our complaints laboratory subscribes to external quality assessment program (eqa) and has tested quality control samples from cap survey organization on a lot of vidas sars cov-2 igm as an ordinary laboratory.The result obtained complied to the expected negative interpretation.The analysis of report issued by cap survey did not highlight any anomaly of vidas peer group.4) conclusion : the complaints laboratory did not reproduce the issue reported by the customer (false positive results) when testing internal samples on sars cov-2 igm lot 1008982120.Without the customer¿s material available, it is not possible to pursue further the investigation and identify any obvious root cause.The phenomena observed by the customer can be due to one or a combination of causes listed below: the quality control sample processed by the customer (e.G stability, homogenization, and handling).The establishment of the range and target.Moreover, according to the analysis of uk neqas report, the target values of 0.92 and 0.49 are not only dedicated to vidas users.It was obtained with a method of 19 or 24 peers while vidas includes only 3 peers.The cvs are very high indicating that there are different methods involved.Finally vidas sars cov-2 igm ref.(b)(4) is not a quantitative test and there is no correlation between the methods which not detect exactly the same target.So the index obtained using vidas cannot be compared to the index obtained using another method.According to the investigation outcomes, there is no reconsideration of sars cov-2 igm ref.(b)(4), lot 1008982120.

• Brand Name: VIDAS® SARS-COV-2 IGM
• Type of Device: VIDAS® SARS-COV-2 IGM
• Manufacturer (Section D): BIOMÉRIEUX SA; 376 chemin de l'orme; marcy l'etoile 69280 ; FR 69280
• Manufacturer (Section G): BIOMÉRIEUX SA; 376 chemin de l'orme; marcy l'etoile 69280 ; FR 69280
• Manufacturer Contact: sandra ; 5 rue des aqueducs; craponne 69290
• MDR Report Key: 15099127
• MDR Text Key: 301137002
• Report Number: 8020790-2022-00085
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: UNCLASSIFIED
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2022
• Device Catalogue Number: 423833
• Device Lot Number: 1008982120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1