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

Catalog Number 30459

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2018

Event Type  malfunction  

Event Description

A customer in (b)(6) reported falsely under-estimated results for two patients in association with the vidas® ft4 assay (lot 1002011310) and a tsh (thyroid) panel on (b)(6) 2018.Each patient sample was tested on two different lots of the ft4 (free thyroxine) assay.The customer stated the calibrations were correct.The euthyroid reference range for ft4 is [0.82-1.5] ng/dl.The results were: patient 1: tsh 1.14 uiu/ml [0.25-5].Ft4 : 0.81 ng/dl (2301 rfv) other lot.Ft4 : 0.14 ng/dl (3227 rfv) lot 1002011310 - too low.Patient 2: tsh 0.84 uiu/ml [0.25-5].Ft4 : 1.36 ng/dl (1794 rfv) other lot.Ft4 : 0.46 ng/dl (2370 rfv) lot 1002011310 - too low.The customer did not report the results for lot 1002011310, but reported results from a different lot.There was no impact on the patients' treatment and there was no delay.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary ag kehler strasse 31, 76437 rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002.Importer: maquet medical systems usa (b)(4).Contact person: (b)(6).The product is not available for investigation in the laboratory of manufacturer.Maquet cardiopulmonary is aware of a similar complaint(703006748) which was investigated as follows:the returned complaint sample was after rinsing with water and a cleaning with sodium hypochlorite,a visual inspection and a leak test according to lv 201(blood side) performed.The leak test according to lv 201(blood side)was performed and on the blood outlet connector(1/4 connector)a leak(cracks) was detected.The cracks could be occurred during return of the device,because the customer did not noticed a leakage on the connector during use.The reported leakage on the disconnector port could be confirmed.Affected product:packaging lot #70117380 and production lot 70117377-70117380,udi-number (b)(4).The avz from (b)(4) (dms# (b)(4)) was reviewed.There were no references found,which are indicating a nonconformance of the product in question.Sap trend search was performed(material 70106.7948,failure code 0104 dialysis lock and valve) which came to following results:2 additional complaints were recorded in last 12 months.Based on the sales figures of the last 12 months following occurrence rate has been calculated:0,1%, which is below 1%.Due to this information no systemic issue could be determined.The failure is already known to the manufacturer and has been thoroughly investigated under capa 17-07-003.The most probable cause of the reported failure is the detected offset which caused a leakage of the o-ring.All further steps will be performed in accordance to capa 17-07-003.

Manufacturer Narrative

An internal biomérieux investigation was performed with results as follows: the reagent vidas® ft4n, and batch number 180924-0 is within the expected performances of the product.The customer's anomaly could not be reproduced on the six (6) samples tested internally.Without returned samples it is not possible to investigate further.Vidas® ft4 result should be interpreted in conjunction with other parameter results (such as tsh) patient clinical context and history, as indicated in the package insert, page 1 (vidas ft4 ref 30459): "the vidas® ft4 test aids in diagnosing thyroid disorders.The ft4 assay must be used in conjunction with other tests, such as tsh, as well as a clinical examination of the patient (4)." it is necessary to perform regular instrument maintenance in order to ensure the mini vidas®, vidas® and vidas 3® are functioning correctly and ensure the quality of your daily results.These procedures are described in the mini vidas®, vidas® or vidas 3® user manuals.

• 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
• MDR Report Key: 7596023
• MDR Text Key: 111436297
• Report Number: 3002769706-2018-00078
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• PMA/PMN Number: K132058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2018
• Device Catalogue Number: 30459
• Device Lot Number: 1006011310
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/16/2018
• Initial Date FDA Received: 06/13/2018
• Supplement Dates Manufacturer Received: 08/09/2018; 08/09/2018
• Supplement Dates FDA Received: 09/07/2018; 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1