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

Catalog Number 30407

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Note: reference (b)(4) is not registered in the united states.The u.S.Similar device is product reference (b)(4).A customer in (b)(6) notified biomérieux of obtaining an out range result for an external instand quality control sample in association with the vidas® fsh 60 tests (ref (b)(4), batch 1007652290).The customer stated out of range low result was obtained when testing instand quality control sample 22.Customer result and specified range are listed below.Sample 22, customer result: 55.1 iu/l, specified range: 55.7 ¿ 85.3 iu/i.As there is no patient associated with this quality control sample, there is no adverse event related to any patient's state of health.Biomérieux has initiated an internal investigation.

Manufacturer Narrative

This report was initially submitted following notification from a customer in germany regarding out-of-range-low (oorl) results for an eqa sample (instand samples 21 and 22) in association with the vidas fsh assay (ref.30407, lot 1007652290).Sample 21: peer group = 3.51 ui / l acceptable range [2.77-4.25] ui / l; customer's result = 2.65 ui / l out of the acceptable range.Sample 22: peer group = 70.5 ui / l acceptable range [55.7-85.3] ui / l; customer's result = 55.1 ui / l out of the acceptable range.A biomérieux investigation was conducted; however, the customer did not submit any sample for testing.Evaluation of manufacturing batch records indicated no anomaly during the stages of manufacture, control and packaging.Analysis of several internal serum sera on seven (7) lots of vidas fsh ref.30407, including customer lot, indicated the lot was in specification and in the trend with the other lots.Investigational testing of the implicated lot with four (4) internal samples and two (2) samples of probioqual showed all results obtained comply with the expected and targeted standards.The lot has not drifted since its release.The anomaly was not reproduced.The issue reported by the customer (low results for samples 21 and 22 external quality control instand) was not reproduced by complaints laboratory with sample available in the laboratory.Without the customer's return sample, further investigation and determination of root cause is not possible.The investigation concluded the kit vidas fsh ref.30407 batch 1007652290 / 200922-0 is within the expected performance.There are no other complaints for eqa control out of range result on this vidas batch.

• 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: 10402471
• MDR Text Key: 205489093
• Report Number: 8020790-2020-00076
• 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: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2020
• Device Catalogue Number: 30407
• Device Lot Number: 1007652290
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1