MAUDE Adverse Event Report: BIOMÉRIEUX SA VIDAS® VARICELLA-ZOSTER IGG; VIDAS® VARICEL. ZOSTER IGG 60 T

Catalog Number	30217
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, a customer in switzerland notified biomérieux of a potential false negative patient result compared to another method (diasorin) when using vidas® varicella-zoster igg (vzg) reference (b)(4) lot 1010385660 (expiry 05-sep-2024).Patient information: elderly female in a medico-social establishment.Testing was performed to recheck immunity, as there are people infected inside the establishment.The issue occurred in (b)(6) 2024 (testing (b)(6)2024).The customer reported a suspected false negative result when testing a patient's sample with result of 0.59 tv (at the upper limit of negative interpretation).Other method (diasorin) results were reported positive on (b)(6) 2024.At the time of this assessment, there is no indication of patient harm, incorrect treatment, nor delay in rendering results.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An internal investigation was performed following a notification from a customer from switzerland who obtained a false negative result when testing a patient¿s sample with vidas varicella zoster igg (ref.30217, lot: 1010385660, expiry date: 05-sep-2024).1.Device history record: the review did not highlight any issue during manufacturing process for vidas varicella zoster (ref.30217, lot 1010385660).There is neither capa, no quality event and nor non-conformity linked to this issue on this vidas assay.2.Complaint analysis: at the date of investigation, no other complaints were recorded for false negative result on vidas varicella zoster (ref.30217 lot 1010385660) whatever the issue and the lot was already expired when the customer reported the issue to the local customer service.3.Test/analysis performed.3.1 control charts analysis: the complaints laboratory analyzed the results of 4 internal samples (2 positive samples at 0.98 and 1.39 tv, an equivocal sample at 0.77 tv and 1 negative sample at 0.48 tv) on 15 different batches of vidas varicella zoster ref.30217 including the customer¿s lot 1010385660.The analysis of the control charts showed that all results are within specifications.Customer¿s lot is in the trend compared to the other lots.3.2 tests performed by complaint laboratory: it was not possible to carry out any test because the lot was already expired when the customer reported the issue to the local customer service.In absence of the concerned sample and without any possible test to perform, the complaint laboratory couldn¿t pursue further the investigation.4.Root cause analysis and conclusion: according to all information above, no anomaly was highlighted with the control chart analysis and the analysis of quality data.The discrepancy observed by the customer couldn¿t be explained as it was not possible to carry out any test on the concerned lot but based on the complaint records file, the issue is considered as isolated.According to the investigation outputs, the performance of the vidas varicella zoster (ref.30217 lot 1010385660) is conform to the expected specifications.
Additional Manufacturer Narrative
In alignment with the most recent fda guidance, ¿medical device reporting for manufacturers, issued november 8, 2016¿, biomérieux is submitting this notification to fda to inform the agency of the decision to cease reporting specific vidas® malfunction events after two years of no occurrences associated with death or serious injury.For the specific combinations of product and malfunction type, customer complaints were reviewed over a two year period starting from the date of awareness of the most recent event that was classified as a serious injury or death.For the following malfunction types, this review identified no additional occurrences of being associated with death or serious injury for two years.Product code: lfy.Reference: (b)(4).Malfunction: false negative for vidas varicella-zoster igg.Date of awareness for serious injury/death: 03jun2022.Final initial mdr submitted: 8020790-2024-00015.Cease reporting decision mdr: 8020790-2024-00015-02.With the completion of our mdr data analysis, we have updated our mdr criteria for vidas product code lfy and will no longer report these malfunction events since they have not caused or contributed to a death or serious injury in the past two years.Moving forward, if biomérieux becomes aware of a death or serious injury event for the product code lfywe will report that event to the fda per the fda mdr guidance and will update our mdr criteria to require reporting the specific associated malfunction as required by this guidance.

• Brand Name: VIDAS® VARICELLA-ZOSTER IGG
• Common Device Name: VIDAS® VARICEL. ZOSTER IGG 60 T
• 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: matthew locus ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 20781169
• Report Number: 8020790-2024-00015
• Device Sequence Number: 13035720
• Product Code: LFY
• UDI-Device Identifier: 03573026064518
• UDI-Public: 03573026064518
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K923122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/05/2024
• Device Catalogue Number: 30217
• Device Lot Number: 1010385660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2024
• Supplement Date Received by Manufacturer: 01/08/2025; 06/30/2025
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 01/10/2025; 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/27/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female