MAUDE Adverse Event Report: BIOMÉRIEUX SA VIDAS® VARICELLA-ZOSTER IGG

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 31-jan-2024, a customer from germany notified biomérieux of obtaining negative result when testing patient sample with vidas varicel.Zoster igg 60 t (ref.30217, batch number: 1010193850, expiry date: 26-may-2024) compared to another method.The customer uses a mini vidas® instrument (serial no.(b)(6)).According to the information provided, the testing was performed on a 32 year old pregnant woman.Instrument: mini vidas® 5.6.1 last preventative maintenance: 15feb2023 qcv test run the (b)(6) 2023 was compliant.Qcv test run the (b)(6) 2023 was compliant.Mle data vz igg ref 30217, lot: 1010193850 s1: 447 ¿ 829 rfv c1: 1.97 ¿ 2.85 c2: <= 0.59 calibration performed the 07nov2023 = > valid s1: 701/640 rfv, mean: 670 rfv.C1: 2.47 (1657 rfv) positive c2: 0.00 (-1 rfv) negative calibration performed on 04jan2024 = > valid s1: 692 / 675 rfv, mean: 683 rfv c1: 2.49 (1701 rfv) positive c2: 0.00 (0 rfv) negative patient sample testing: vz igg testing with vidas lot 1010193850 performed on (b)(6) 2023; performed with calibration valid from 07nov2023.Result: (0.50) neg vz igg testing with vidas lot 1010193850 performed on (b)(6) 2024; performed with calibration valid from 04jan2024.Result: (0.48) neg vz igg vidas interpretation: negative < 0.60 equivocal >=0.60 < 0.90 positive > 0.90 same sample tested on mini vidas® from 23jan2024 was tested with liaison.Vz igg with liaison positive (156 mui/ml) vz igm with liaison negative (0.20 ) vz igg liaison (diasorin) interpretation: negative < 50 mui/ml equivocal 50 ¿ 100 mui/ml positive > 100 mui/ml there was no treatment of the patient due to the first negative result.In addition, the customer confirmed there was no patient harm or impact, nor delayed results.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
This report was initially submitted following notification from a customer in germany regarding negative result when testing patient sample with vidas varicel.Zoster igg 60 t (ref.(b)(4), batch number: 1010193850, expiry date: 26-may-2024) compared to another method.The customer uses a mini vidas® instrument (serial no.(b)(6)).A biomérieux internal investigation has been completed with the following results: customers material: ********************************** no patient¿s sample available.Investigation outcomes: *************************************** complaint analysis: ------------------------------------------- at the time of investigation, there is only the customer¿s complaint, in link with object of this issue, recorded on vidas varicella-zoster igg (vzv) ref.(b)(4) lot 1010193850.Quality control records: ------------------------------------- there is neither capa, quality event nor non-conformity linked to this issue on this vidas assay.Analysis and tests conducted by complaints laboratory.------------------------------------------------------------------------------- **control chart analysis** ~~~~~~~~~~~~~~~~~~~~ this analysis was carried out: on (b)(4) internal samples ( positive samples) with a respective target at 1.31 / 1.39 / 1.52 and 2.05 tv.- on (b)(4) batches of vidas varicella-zoster igg (vzv) ref.(b)(4) including the lot 1010193850 used by the customer.The analysis of the control charts showed that all results are within specifications and the lot mentioned above is in the trend compared to the other lots.***tests performed by the complaint¿s laboratory*** ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ our complaints laboratory tested (b)(4) internal samples, (b)(4) negative and (b)(4) positive ones , (targets: 0.48 tv, 1.31tv, 1.39 tv, 1.52 tv and 2.05 tv) on the retain kit of vidas varicella-zoster igg (vzv) lot 1010193850.=> samples results are within their expected specifications.There is no change of interpretation of the samples.No evolution was noticed over time of the batch number 1010193850.Conclusion: **************** according to all information above, no anomaly was highlighted with the control chart analysis, the analysis of quality data and the tests performed on our internal quality control materials using the retain kit of vidas varicella zoster igg ref (b)(4) lot 1010193850.Without customer's return sample and kit, further investigation cannot be pursued.The result observed using vidas varicella zoster could be due to how the igg antibodies targeted with this test are linked with the immune status of the patient.The clinical context of the patient is not known if they are immunocompetent, immunosuppressed or vaccinated.Moreover, with only these two values (vidas vzv igg negative and liaison vzv igg positive) we cannot establish which result is more accurate for determining the patient varicella -zoster immunological status.Unfortunately, sample was not available to be retested with a third method.For reminder, vidas varicel.Zoster igg ref 30217 assay only detects igg and it is intended as an aid in the determination of immunological experience with varicella-zoster virus.There is no consensus regarding the protective rate of anti-varicella-zoster antibodies.As it is recommended in the package insert, if a definitive determination of immunity is required, all persons with negative results should be retested by a more sensitive assay, e.G.Fama.According to the data mentioned above, there is no reconsideration of vidas varicella-zoster igg ref.(b)(4) lot 1010193850.

• Brand Name: VIDAS® VARICELLA-ZOSTER IGG
• Common Device Name: VIDAS® VARICELLA-ZOSTER IGG
• Manufacturer (Section D): BIOMÉRIEUX 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: danielle cooper ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 18644697
• Report Number: 8020790-2024-00002
• Device Sequence Number: 7129136
• Product Code: LFY
• UDI-Device Identifier: 03573026064518
• UDI-Public: 03573026064518
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 03/27/2024

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: 05/26/2024
• Device Catalogue Number: 30217
• Device Lot Number: 1010193850
• 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: 01/31/2024
• Supplement Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 02/05/2024
• Supplement Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Female