MAUDE Adverse Event Report: BIOMÉRIEUX SA 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 Date 09/19/2016

Event Type  Injury  

Event Description

A customer in italy notified biomérieux of discrepant results associated with vidas® ft4 assay (reference (b)(4)).On (b)(6) 2016 a high result (51.09 pmol/l) was obtained and the test was repeated on the next day ((b)(6) 2016) with a result of 49.51 pmol/l.The result 49.51 pmol/l was communicated to the patient.On (b)(6) 2016 the patient returned for a repeat test.The test result 45.81 pmol/l and was reported to the patient.The patient underwent endocrinology examination, ultrasound scans, and analysis in other areas to exclude any disease, but all results came back normal.The patient went to another lab and the ft4 result was normal.The patient returned to the customer's site on (b)(6) 2016 to repeat the ft4 test and the result was 45.10 pmol/l.The patient returned to the customer's site on january 7, 2017 for a repeat test and the result was 43.10 pmol/l.An alternative test electrochemiluminescence method was also performed and the result was 15.79 pg/ml (normal result) culture submittals have been requested by biomérieux for internal investigation.An internal biomérieux investigation has been initiated.

Manufacturer Narrative

This follow-up report is being submitted to correct the event from a malfunction event to an adverse event because the patient underwent medical evaluation/testing based upon the erroneous device result.

Manufacturer Narrative

This report was initially submitted following notification that a customer in italy experienced discrepant vidas® ft4 results as compared to an alternate method (cobas).Biomérieux investigation was conducted.Analysis of the batch history records shows no anomaly during the control process for vidas® ft4 lot 1004792690.Review of complaint history identified no other complaints registered for the referenced lot for the described issue.Testing was performed using the customer lot and a random lot of vidas® ft4; the sample tested was submitted by the customer.The investigational testing obtained overestimated results similar to the customer's results.Several interference tests were performed on the sample submitted by the customer; no origin of interference was identified (heterophilic antibodies or rheumatoid factors).The vidas® ft4 package insert indicates "assay results should be interpreted as part of a complete clinical evaluation and thyroid function assessment, including at least tsh determination." the investigation concluded the overestimated values may be the result of drug interference or cross-reaction with another substance, and is directly related to the patient sample.The vidas® ft4 package insert also indicates "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." the vidas® ft4 lot 1004792690 assay is performing as expected.

• Brand Name: VIDAS® FT4 ASSAY
• Type of Device: VIDAS® FT4 ASSAY
• Manufacturer (Section D): BIOMÉRIEUX SA; chemin de l orme; marcy l etoile, rhone 69280; FR
• Manufacturer (Section G): BIOMÉRIEUX SA; chemin de l orme; marcy l etoile, rhone 69280; FR
• Manufacturer Contact: ellen weltmer ; 595 anglum road; saint louis, MO 63042
• MDR Report Key: 6313949
• MDR Text Key: 67213991
• Report Number: 3002769706-2017-00021
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup
• Report Date: 04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2017
• Device Catalogue Number: 30459
• Device Lot Number: 1004792690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention