MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® VARICELLA IGG

Catalog Number	30217
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the (b)(6) notified biomérieux of discrepant results associated with vidas® varicella (igg) (reference 30217).The customer reported running three (3) patient samples using a new lot of product and the results were: 1 negative, 1 equivocal and 1 positive.The results for sample no.(b)(4) during the week of (b)(6) 2018 on the old lot were reported as 3.18.Yesterday ((b)(6) 2018) using new lot the result was 3.92 and 3.25 while running the sample on the old lot.The results for sample no.(b)(4) during the week of (b)(6) 2018 on the old lot were reported as 0.12.Yesterday ((b)(6) 2018) using new lot the result was 0.14 and 0.13 while running the sample on the old lot.The results for sample no.184027728 during the week of 26mar2018 on the old lot were reported as 0.80.Yesterday (04apr2018) using new lot the result was 1.05 and 0.91 while running the sample on the old lot.The customer is concerned with results for sample (b)(4).The sample was reported last week as an equivocal result with a value of 0.80.Yesterday ((b)(6) 2018) on the new lot the results obtained were 1.05.The customer is concerned that equivocal results could be reported as positives using the new lot when compared to the previous lots.The customer reported these discrepant results lead to a delay of greater than 24 hours.There is no known impact to the patient due to the discrepant and delayed results.
Additional Manufacturer Narrative
A customer in the united kingdom notified biomérieux of discrepant results associated with vidas® varicella igg (reference 30217).An investigation was performed.The customer reported non-reproducible results between two batches (1006046000 and 1006161020) of vidas varicella igg (vzg).The customer did not submit samples for evaluation.The analysis of the batch history records showed no anomaly during manufacturing and control processes.The analysis of the control charts for five (5) internal sera on five (5) vidas vzg batches (including customer lots) showed that lots are within specifications and the two customer lots are in the trend of the other batches.Four (4) internal samples near the positive cut off (0.90) were tested on the two batches mentioned by customer.All results were conforming and within specifications.A result similar to those obtained by customer was observed for one internal sample (equivocal interpretation instead of positive interpretation expected).This is not considered as a change of interpretation and result is within specifications.As indicated in the package insert: "the imprecision inherent in any method implies a lack of confidence in samples with test values very close to the thresholds.Consequently, an equivocal zone is established between the thresholds based on a statistical understanding of this imprecision.Equivocal samples should be repeated with a fresh specimen.If it is impractical to obtain a fresh specimen, repeat the assay with the original specimen (provided it is not microbially contaminated or lipemic).If the sample repeats as an equivocal, test it using another method." in conclusion, the vidas vzg lots 1006046000 and 1006161020 are within the expected specifications.

• Brand Name: VIDAS® VARICELLA IGG
• Common Device Name: VIDAS® VARICELLA IGG
• Manufacturer (Section D): BIOMERIEUX SA; 376, chemin de l'orme; marcy l'etoile, 69280 ; FR 69280
• MDR Report Key: 7476873
• Report Number: 3002769706-2018-00061
• Device Sequence Number: 13850959
• Product Code: LFY
• UDI-Device Identifier: 03573026064518
• UDI-Public: 03573026064518
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K923122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2018

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: 09/26/2018
• Device Catalogue Number: 30217
• Device Lot Number: 1006161020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2018
• Supplement Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 05/01/2018
• Supplement Report FDA Received Date: 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1