MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS FSH 60 TESTS; VIDAS® FSH 60 TESTS

Catalog Number 30407

Device Problem High Test Results (2457)

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

Event Date 05/10/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021, a customer from (b)(6) reported to biomerieux that they observed out of range high results when testing quality control samples with vidas® fsh 60 tests ¿ ref.30407, batch 1008580750, expiry date 08-feb-2022.The external qc samples were instand and the results obtained on (b)(6) 2021 were the following : sample 31: 45.39 iu/l (expected result 36.5 [28.8 ¿ 44.2] iu/l).Sample 32: 21.62 iu/l (expected result 18.0 [14.3 - 21.8] iu/l).Sample 31 gave an out of range high result and sample 32 gave a result that was in the acceptable range, but close to the upper limit.At time of reporting, calibration results were not provided for the calibration preceding the results but for a more recent one which was valid.There was no patient involved as it was external quality control samples.Biomérieux has initiated an internal investigation.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 notification from a customer in germany that they obtained high results when using an external quality control sample (instand group 297_samples 31 and 32) in association with vidas fsh (ref# (b)(4),lot#1008580750).Investigation results: analysis of the batch history records for lot# 1008580750 showed no anomaly during the manufacturing, control and packaging processes.Control charts: the investigator looked at control charts for 5 internal sera (targets: 14.6 miu / ml, 21.6 miu / ml, 65.7 miu / ml, 88.7 miu / ml and 3.15 miu / ml), using 7 batches (including the vidas fsh 1008580750).All values were within specifications, customer's lot is consistent with the other lots.Testing the complaint laboratory then tested a calibration sample along with 2 internal samples (targets 15.9 mui / ml, 23.10 mui / ml) and 1 external quality control from probioqual (french external quality control provider; target: 36.60mui / ml) using retain kit vidas fsh 1008580750.All of the results obtained were within the acceptable ranges were comparable to those observed before the batch release.Biomérieux did not observe any drift in the result values.Conclusion according to all information above, no anomaly was highlighted with the control chart analysis, the analysis of quality data and the tests performed with the retain kit.The complaints laboratory was unable to reproduce the customer¿s issue.Without customer's return sample, we cannot pursue further investigation nor propose a root cause to the customer's issue.The investigation unit laboratory studied the results of the 2020 and 2021 campaigns of the external quality assessment (eqa) proposed by probioqual for the fsh parameter for the peer group using the vidas fsh test.Satisfactory intra-technical variability (cv) for all samples analyzed with different batches of vidas fsh during the 2020 and 2021 campaigns.The results observed by customer could be explained by: 1) the interlot variability characteristic of any diagnostic test; 2) the pre analytic step: volume, waiting time, mixing; 3) the matrix effect as mentioned in the clsi guideline ep14-a3 that processed samples used as qc material (eg eqa): ¿current scientific data suggest that such use of pt / eqa results is not always feasible because of matrix effects.These processed materials us as pt / eqa samples sometimes do not behave like patient samples routinely analyzed in the laboratory.Biases not generally seen with fresh biological fluids, are frequently seen with pt / eqa samples ¿ according to the above data, the kit vidas fsh ref.(b)(4) batch 1008580750 is within the expected performance.

• Brand Name: VIDAS FSH 60 TESTS
• Type of Device: VIDAS® FSH 60 TESTS
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile 69280 ; FR 69280
• MDR Report Key: 12242567
• MDR Text Key: 281747294
• Report Number: 8020790-2021-00173
• Device Sequence Number: 1
• Product Code: CGJ
• Combination Product (y/n): N
• PMA/PMN Number: K921746
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/08/2022
• Device Catalogue Number: 30407
• Device Lot Number: 1008580750
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1