MAUDE Adverse Event Report: BIOMERIEUX, S.A. VIDAS® FT4 ASSAY

Catalog Number 30459

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Type  malfunction  

Event Description

A customer in (b)(6) reported to biomérieux a falsely overestimated result for a (b)(6) female patient in association with vidas® ft4 (lot 1005780750).The vidas® ft4 result (27.04 pmol/l), was reported to the patient and to the physician.The physician did not accept the ft4 result because it did not correlate with the patient's clinical status (nontoxic nodular goiter not treated), and requested testing with another laboratory.The results were: (b)(6).There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer in (b)(6) reported to biomérieux a falsely overestimated result for a (b)(6) year old female patient in association with vidas® ft4 (lot 1005780750).An investigation was performed.A review of quality records confirmed there were no nonconformances during the manufacturing of lot 1005780750.Testing included a calibration and five internal samples distributed on the measurement range on the vidas® ft4 (lot 1005780750) retained kit.Ft40032 = 36.16 pmol/l ([22.4-47.6] pmol/l); ft40006 = 23.87 pmol/l ([14.1-30.1] pmol/l); ft40005 = 11.77 pmol/l ([8.19-17.4] pmol/l); aj001 = 6.81 pmol/l ([5.71-8.83] pmol/l); ft40040 = 1.54 pmol/l ([0.00-1.99] pmol/l).The results obtained for the calibration and for these five samples were within the specifications.There was no significant drift of the batch since its release.The control charts of these five internal samples and another internal sample (in the high part of the measurment range) were studied with twelve different batches of vidas® ft4 including the batch used by the customer (1005780750): all the results are within the specifications and all the batches are in the trend of the vidas® ft4 parameter.According to all the data above, the vidas® ft4 lot 1005780750 performed as expected.As the customer did not provide us the sample, we cannot pursue further the investigation and explain the reason of the discrepancy.An interference has probably occurred, as indicated in the package insert - limitations of the method : "interference may be encountered with certain sera containing antibodies directed against the 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® FT4 ASSAY
• Type of Device: VIDAS® FT4 ASSAY
• Manufacturer (Section D): BIOMERIEUX, S.A.; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX, S.A.; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer Contact: ellen weltmer ; 595 anglum road; st. louis, MO 63042 ; 3147317301
• MDR Report Key: 7025690
• MDR Text Key: 92993093
• Report Number: 3002769706-2017-00357
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K132058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/06/2018
• Device Catalogue Number: 30459
• Device Lot Number: 1005780750
• Other Device ID Number: 03573026240400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR