MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® FT4

Catalog Number 30459

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer in (b)(6) reported the occurrence of discrepant 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 discrepant result was not provided to the treating physician; therefore the vidas result had no impact on patient treatment.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 a false positive result on vidas® ft4 (lot 1004908050) obtained on vidas® system vn03499 on (b)(6) 2016.The false positive result on ft4 was obtained on position a03: 266 rfv ( >100 pmol/l).The customer performed a retest on position c3: 1451 rfv (18.67pmol/l) which was interpreted as a good result according to patient history.The negative result obtained during retest had been reported to the clinician.Both tests were performed in automatic pipetting mode.A field service engineer tested the system on 22sep2016 and did not find any issue with the instrument (fot, opt and pump).A biomerieux internal investigation was conducted.The analysis of the vidas® system log was able to exclude potential causes : - problem of transfer of the liquid by the pipettor because correct pressures values were recorded.- persistent leakage / blocked channel in the position a03 because no leakage or blocked channel have been observed on the system.- pump operation issue (protocol performed by the pump) because the rfv values during duplicates / triplicates are correct.A review of quality records found no issue with the manufacturing and control process of the batch.There was no issue found with testing of the retained kit and the returned customer kit and sample.For the reasons above, the potential cause of the issue may be the pre-analytics steps.The package insert, vidas® ft4 ref 30459, highlights the importance of specimen type and collection: human serum or plasma (lithium heparin).Do not use edta tubes.According to the package insert, the interpretation of test results should be made taking into consideration the patient's history.

• 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; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 6042247
• MDR Text Key: 57981583
• Report Number: 3002769706-2016-00449
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 03/15/2017

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: 05/18/2017
• Device Catalogue Number: 30459
• Device Lot Number: 1004908050
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2016
• Initial Date FDA Received: 10/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/15/2017
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR