MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® CMV IGG

Catalog Number 30204

Device Problem Component Missing (2306)

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

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomerieux of observing delayed results on 4 patient samples when using vidas cmv igg 60 tests, lot 1008757110, expiry date = 15-apr-2022.There were sprs missing in two kits of vidas cmv igg 60 tests, lot 1008757110 : one spr missing in the first kit, and five sprs missing in the second kit.As a consequence of this issue, the customer was unable to proceed with testing and there were delayed results of over 24 hours for 4 patients.There is no indication or report from the laboratory that the delayed results led to any adverse event related to any patient's state of health.An internal investigation was initiated.

Manufacturer Narrative

An internal investigation was performed following notification from a customer in israel of observing delayed results on 4 patient samples, due to missing sprs, when using vidas® cmv igg 60 tests, lot 1008757110, expiry date = 15-apr-2022).Investigation device history record and complaint analysis the analysis of the batch history record for the vidas cmv igg ref 30204 lot 1008757110 showed no anomaly during the manufacturing, control and packaging processes.No non-conformity nor capa is linked to the customer¿s complaint recorded on vidas cmv igg ref 30204 lot 1008757110.There is no other similar complaint on vidas cmv igg ref 30204 lot 1008757110.Analyses were done on retained kit vidas cmv igg ref 30204 lot 1008757110.The investigation laboratory verified the number of sprs per pouch of kit vidas cmvg ref 30204 lot 1008757110.The two pouches contain 30 sprs each.Analysis of the manufacturing and packaging files, carried out by the industrialization department, showed no anomalies.Conclusion: customer anomaly was not reproduced with the retain kit.The issue observed by customer may be linked to internal operator error during the packaging process.Based on investigation findings, there is no reconsideration on vidas® cmv igg ref 30204 lot 1008757110 performance.

• Brand Name: VIDAS® CMV IGG
• Type of Device: VIDAS® CMV 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: candace martin ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 13047680
• MDR Text Key: 290177361
• Report Number: 8020790-2021-00367
• Device Sequence Number: 1
• Product Code: LFZ
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K920661
• 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: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2022
• Device Catalogue Number: 30204
• Device Lot Number: 1008757110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1