MAUDE Adverse Event Report: BIOMERIEUX 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 (b)(6) 2023, a customer from france notified biomérieux of obtaining negative result when testing patient sample with vidas varicel.Zoster igg 60 t (ref.30217, batch number: 1009987800, expiry date: 21-jan-2024) compared to another method.The customer performed test on one (1) patient sample, he obtained the following results: patient test on (b)(6) 2023 : 0.46 tv (negative result).He compared with another method (test on liaison diasorin) : 212 mui/ml.Neg < 50 mui/ml.Equiv 50 - 100 mui/ml.Traces 101 - 150 mui/ml.Pos > 150 mui/ml.Calibration was done 06-oct-2023 and was valid.S1 : 670/672 rfv [481-894] rfv.C1 : 1469 rfv -> 2.18 vt [1.92-2.78] tv.C2 : 0 <0.59 tv.At the time of this assessment, the customer did not provide information regarding clinical context, delay result or any indication of patient impact.A biomérieux internal investigation has been initiated.
Additional Manufacturer Narrative
Corrected inadvertent section b1 selection of "adverse event" to the correct selection of "product problem".
Additional Manufacturer Narrative
1) context of the complaint a french customer complained about a negative result (0.46 tv) observed when testing a patient¿s sample on vidas® varicella-zoster igg ref.30217 lot 1009987800 compared to the positive result observed using a competitor method.2) customers material no patient¿s sample available 3) investigation outcomes 3-1) complaint analysis the complaint analysis did not reveal this issue as a systemic quality issue.3-2) analysis and tests conducted by complaints laboratory control chart analysis this analysis was carried out: on four (4) internal samples (3 positive samples and a negative one) with a respective target at 0.42 / 1.14 / 1.31 and 2.05 tv.On seven (7) lots of vidas varicella-zoster igg (vzv) ref.30217 including the lot 1009987800 used by the customer.The analysis of the control charts showed that all results were within specifications and the lot mentioned above is in the trend compared to the other lots.As the customer¿s lot was expired at the date of the investigation, it was not possible to perform any test on the retain kit of varicella-zoster igg lot 1009987800.The complaints laboratory subscribes to external quality assessment programs and tests different quality control samples from uk neqas organization such as an ordinary laboratory.During 2023, the complaints laboratory participated in 2 challenges from immunity screen program and tested 12 quality control samples including 8 positive samples.All the results complied to expectations.According to uk neqas report, all the vidas® users reported results complying with expected interpretation for all these samples.Moreover, the number of participants using vidas varicella-zoster igg method is between 68 and 72 depending on the challenge, this is in favor between lot distribution.Without any patient¿s sample available and clinical history context, further investigation could not be pursued to explain the discrepancy observed by this customer.4) conclusion because the customer¿s lot was expired at the date of the investigation, it was not possible to perform any test on the retain kit of varicella-zoster igg lot 1009987800.However, based on the analysis of data history and analysis of quality control samples, there is no reconsideration of performances for varicella-zoster igg (vzv) ref.30217 lot 1009987800.

• Brand Name: VIDAS® VARICELLA-ZOSTER IGG
• Common Device Name: VIDAS® VARICELLA-ZOSTER IGG
• 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: romain marti ; 5 rue des acqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 18344161
• Report Number: 8020790-2023-00050
• Device Sequence Number: 6268934
• Product Code: LFY
• UDI-Device Identifier: 03573026064518
• UDI-Public: 03573026064518
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/21/2024
• Device Catalogue Number: 30217
• Device Lot Number: 1009987800
• 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: Not provided
• Supplement Date Received by Manufacturer: 12/07/2023; 02/07/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 12/19/2023; 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown