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

Catalog Number 30407

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Event Description

Intended use: vidas fsh is an automated quantitative test for use on the vidas family instruments for the determination of human follicle stimulating hormone in human serum or plasma (lithium heparin), using the elfa technique (enzyme linked fluorescent assay).Issue description: on (b)(6) 2021, a customer from (b)(6) reported to biomerieux that they observed out of range high results when testing an external quality control sample with vidas fsh 60 tests ¿ ref.30407, batch 1008522020 , expiry date 14-jan-2022.The external qc sample was seronorm lyo level 2.Seronorm lyo level 2 out of rilibäk range level 2: target 32.30 (range: 27.78 - 36.82) iu/l, 14% deviation allowed.The customer performed the testing with a valid calibration but the results were too high.So the customer performed another calibration using a different batch (batch #1008580750) and level 2 was within the expected range.The customer received a value of 38.14 iu/l (batch# 1008522020) with the first lot and 30.52 (batch #1008580750) with the second lot.There was no patient involved as it was an external quality control sample.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 notification from a customer from germany that they obtained ¿out of range high¿ results when testing an external quality control sample with vidas fsh 60 tests (ref.(b)(4) lot# 1008522020 , exp.14-jan-2022).Investigation: device history review the device history record review showed no issues occurred during manufacturing for vidas fsh (ref(b)(4) lot 1008522020).Control chart analysis: the complaints laboratory analyzed the control charts for 4 internal samples (targets at 5.78, 14.6, 21,6 and 27.8 iu/l) using 7 batches of vidas® fsh tests, including the customer¿s lots.The analysis showed that all results are within specifications, and the results from the customer¿s lot were consistent with those from the reference lots.Testing: the customer's samples were not submitted for the investigation.As a result, tests were performed on internal samples, retained by biomérieux from the production of the lot.Three samples (targeted at 5.78, 21.63 and 27.75 ui/l) were tested using retained kits of the customer¿s lot and one other lot 1008940110, as a reference.All the results are within specifications.The results with vidas fsh lot 1008522020 are similar to those obtained before the batch release and to the reference lot.Analysis of results of another eqa program (probioqual): the complaints laboratory subscribes to different eqa scheme and tests several quality control samples such as an ordinary user.All the results complied to the supplier expectation and the peer group variability is conform to vidas fsh specification.Conclusion: per the investigation information, no anomaly was highlighted with the control chart analysis, the analysis of quality data, nor the tests performed on internal samples with the retain kit vidas fsh lot 1008522020.The investigation did not manage to identify any obvious root cause.Without the customer sample, no further investigation can be performed.According to the above data , vidas fsh lot 1008522020 is within the expected performance.

• Brand Name: VIDAS® FSH 60 TESTS
• Type of Device: VIDAS® FSH 60 TESTS
• 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: 12706920
• MDR Text Key: 284807219
• Report Number: 8020790-2021-00199
• Device Sequence Number: 1
• Product Code: CGJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2022
• Device Catalogue Number: 30407
• Device Lot Number: 1008522020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1