MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® ESTRADIOL II

Catalog Number 30431

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of falsely over-estimated results in association with the vidas® estradiol ii assay (ref.30431, lot 1007168380) processed on a vidas 3 instrument.Test results ((b)(6) year-old female): vidas estradiol ii result - 415 pg/ml.Vidas estradiol ii repeat result - 382 pg/ml.External laboratory result - 192 pg/ml.Patient is menopausal receiving hormone replacement therapy.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.The patient sample was requested for submission.Biomérieux investigation will be initiated.Note: although product reference 30431 is not sold or distributed in the united states, a similar product (ref.30431-01) is registered/sold in the united states.

Manufacturer Narrative

An internal investigation was performed following a customer report of falsely elevated results for two female patients in association with the vidas® estradiol ii assay (ref.30431, lot 1007168380).The customer reported the results were discrepant between vidas estradiol ii and results obtained from an external laboratory.Biomérieux requested the patient samples, however they were not submitted for the investigation.The investigation included a review of quality control records and internal sample control charts, as well as testing on internal and external samples with vidas estradiol ii lot ref 30431 lot 1007168380 / 200219-0.Quality control records: the review of vidas estradiol ii batch history records for lot 1007168380 / 200219-0 showed no anomaly during the manufacturing, control and packaging processes.There is neither capa nor non-conformity recorded on vidas estradiol ii test reference 30431 1007168380 / 200219-0 linked to the customer's issue.Study of internal samples control charts: this analysis was carried out : - on five (5) internal samples with targets close to the results obtained by the external laboratory.- on seven (7) batches including the batch mentioned by the customer compared to six other batches.All the results are within specifications and in the trend of the other lots.Internal testing performed: internal testing was performed on internal samples with the vidas estradiol ii assay, lot 1007168380 / 200219-0 and vidas estradiol ii batch 1007566940/200520-0.The complaints laboratory tested five (5) internal samples and four (4) fresh blood donor samples collected from women over the age of sixty.Vidas estradiol ii assay, lot 1007168380 / 200219-0 show no overestimated results.Conclusion: the investigation showed no anomalies during the manufacturing process, no overestimated results were obtained during testing with five (5) internal samples and four (4) fresh blood samples.Based on this data, the kit vidas estradiol ii ref 30431 lot 1007168380 / 200219-0 is within the expected performance parameters.The vidas estradiol ii instructions for use (ifu) "limitations of the method" section states: do not use the vidas® estradiol ii assay to measure estradiol levels in patients undergoing fulvestrant therapy.Interference may be encountered with certain sera containing antibodies directed against reagent components.For this reason, assay results should be interpreted taking into consideration the patient's history, and the results of any other tests performed.

• Brand Name: VIDAS® ESTRADIOL II
• Type of Device: VIDAS® ESTRADIOL II
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280, ; FR
• MDR Report Key: 9162985
• MDR Text Key: 207937323
• Report Number: 8020790-2019-00058
• Device Sequence Number: 1
• Product Code: CHP
• Combination Product (y/n): N
• PMA/PMN Number: K955647
• 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: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2020
• Device Catalogue Number: 30431
• Device Lot Number: 1007168380
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR