MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® FSH

Catalog Number 30407

Device Problem Low Test Results (2458)

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

Event Type  malfunction  

Event Description

A customer in uruguay notified biomerieux that they observed underestimated results when testing quality control samples with vidas fsh 60 tests ¿ ref.30407, batch 1009124050, expiry date 03-dec-2022.The external qc sample was tested as part of the proficiency testing challenge (subscription 178963 / bche 432).The quality control is cecc.The results were the following: - sample a: 20.92 miu/ml; expected result 29.60 [22.2 - 37.0] miu/ml - sample b: 6.29 miu/ml; expected result 9.99 miu/ml [7.4 - 12.5] miu/ml the target values are the ones from the vidas peer group.There was no patient involved as it was external quality control samples.No further information were available at the time of this assessment.A biomérieux internal investigation will be initiated.Note: reference 30407 is not registered in the united states.The u.S.Similar device is product reference 30407-01.

Manufacturer Narrative

An internal investigation was performed following a notification from a customer in uruguay that they obtained underestimated results during proficiency testing challenge using vidas fsh 60 tests (ref.30407, lot 1009124050, expiry date 03-dec-2022).Investigation results: no material was received from the customer.1.Complaint analysis.At the date of investigation, no other complaints were recorded for underestimated results on vidas fsh 60 tests (ref.30407, lot 1009124050).2.Tests/analysis performed by complaints laboratory.2.1.Control chart analysis.This analysis was carried out on four (4) internal samples with respective targets at 8.24/ 9.15 / 21.6 / 27.8 miu/ml using seven (7) batches of vidas fsh including the customer¿s lot 1009124050.The analysis of the control charts showed that all results are within specifications and the lot mentioned by the customer is in the trend compared to the other lots.2.2.Tests performed on retained kits using internal samples.Biomérieux's complaints laboratory tested four (4) internal samples with targets at 8.24 / 9.15 / 21.6 / 27.8 miu/ml using the retained kits of vidas fsh lot 1009124050 (customer¿s lot) and vidas fsh lot 1009014410 (lot used as a reference).The internal samples' targets were close to the ones of the concerned quality control samples a and b from the customer's complaint (29.69 and 9.99 miu/ml).The results obtained complied to the expectations with no significant difference compared to the results observed before the batches' release.There was no observed evolution over time of the samples' activity between both lots.Conclusion: anomaly (underestimated results) was not reproduced when testing internal samples with targets close to the ones of the concerned quality control samples from the complaint.Without the concerned quality control samples available, the investigation could not be further pursued.Therefore, no obvious root cause explaining customer¿s results could be identified.The phenomena observed by the customer can be due to one or a combination of causes listed below: - quality control samples' processing by the customer (e.G reconstitution, stability, homogenisation, and handling).- calibration results.- establishment of the range and targets (very low number of participants).According to the data mentioned above, there is no reconsideration of the performances of vidas fsh lot 1009124050.

• Brand Name: VIDAS® FSH
• Type of Device: VIDAS® FSH
• Manufacturer (Section D): BIOMERIEUX 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: dima amro ; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 15061479
• MDR Text Key: 304790356
• Report Number: 8020790-2022-00082
• Device Sequence Number: 1
• Product Code: CGJ
• Combination Product (y/n): N
• Reporter Country Code: UY
• PMA/PMN Number: K921746
• 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: 08/30/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2022
• Device Catalogue Number: 30407
• Device Lot Number: 1009124050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2022
• Initial Date FDA Received: 07/19/2022
• Supplement Dates Manufacturer Received: 08/01/2022
• Supplement Dates FDA Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1