MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® FT4

Catalog Number 30459-01

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2017

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in (b)(6) reported the occurrence of falsely underestimated results in association with the vidas® ft4 assay (ref.30459).While product 30459 is not sold or distributed in the united states, a similar product (vidas® ft4, ref.30459-01) is.The customer stated the discrepant vidas® ft4 result was not reported to the physician; therefore the discrepant result had no impact on patient therapy, although results were delayed two days) due to retesting.The discrepant result did not lead to any adverse event related to a patient's state of health.Culture submittals have been requested by biomérieux for internal investigation.An internal biomérieux investigation has been initiated.

Manufacturer Narrative

A customer reported the occurrence of falsely underestimated results in association with vidas® ft4 lot 1005291190.An investigation was performed.An analysis of customer results highlighted important variations of inter and intra-batch results in vidas® ft4 : -the intra-lot analysis (vidas® ft4 lot 1005291190) show variations from 3% to 23% and a possible change of interpretation, -the inter-batch analysis (vidas® ft4 lots 171102-0 and 171116-0) show variations from 10% to 28% and a possible change of interpretation from one lot to another lot.A review of quality records for vidas® ft4 lot 1005291190 confirmed it was within specifications.The quality product laboratory tested 5 internal samples with an euthyroid interpretation and obtained the following results : (b)(6).All samples were within the expected range.A repeatability test was performed with five (5) repetitions using a pool of serum (blood donors samples) on vidas® ft4 lot 1005291190 and obtained the following variability results : (b)(4) the quality product laboratory reproduced the customer's anomaly.As a consequence, distribution of vidas® ft4 reference 30459 lot 1005291190 was stopped 04apr2017 through product stop shipment number (b)(4).Then field safety corrective action number (b)(4), including a customer letter, was issued 20apr2017.Customers were asked to discontinue use and discard any remaining inventory of the vidas® ft4 reference 30459 lot 1005291190, identify any possible false result, analyze the related risks and determine appropriate actions if relevant.Further investigations using vidas® ft4 reference 30459 lot 1005291190 were performed to identify the root cause of this reproducibility issue.The investigation concluded that due to a difference of signal observed between the strips used in lot 1005291190, a part of the test does not perform properly and that can lead to a possible interpretation's change depending on the variation in the signal measured.This signal decrease seems to be due to a production shutdown linked to conjugate well #4.This conjugate solution was tested, and no contamination was highlighted.The investigations cannot be pursued further.

• Brand Name: VIDAS® FT4
• Type of Device: VIDAS® FT4
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX SA; 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: 6344138
• MDR Text Key: 67835104
• Report Number: 3002769706-2017-00032
• 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: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2017
• Device Catalogue Number: 30459-01
• Device Lot Number: 1005291190
• Other Device ID Number: 03573026240400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2017
• Initial Date FDA Received: 02/20/2017
• Supplement Dates Manufacturer Received: 06/12/2017
• Supplement Dates FDA Received: 07/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1