MAUDE Adverse Event Report: ROCHE DIAGNOSTICS FT4, FREE THYROXINE; RADIOIMMUNOASSAY, FREE THYROXINE

Catalog Number 06437281190

Device Problem High Test Results (2457)

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

Event Date 06/10/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer complained of erroneous results for 2 patients tested for free thyroxine (ft4 ii), ft3 - free triiodothyronine (ft3 iii), and thyrotropin (tsh).It is not known if erroneous results were reported outside of the laboratory.This medwatch will cover ft4 ii.Refer to medwatch with (b)(6) for information on the ft3 iii erroneous results and medwatch with (b)(6) for information on the tsh erroneous results.On (b)(6) 2015 patient 1 initial tsh result was approximately 1.2 uui/ml, the ft4 ii result was over 2 times the upper reference range (the specific result was not provided), and the ft3 iii result was over 2 times the upper reference range (the specific result was not provided).A new sample was obtained on (b)(6) 2015 and the initial tsh result was approximately 1.2 uui/ml, the ft4 ii result was over 2 times the upper reference range (the specific result was not provided), and the ft3 iii result was over 2 times the upper reference range (the specific result was not provided).Both samples were repeated on an abbott instrument where the tsh result was in the normal range and the ft4 ii and ft3 iii results were just below the upper reference range.There is a suspicion that this patient sample contains a resistance for thyroid hormone.Patient 2 initial tsh result was 0.64 uui/ml, the ft4 ii result was 77 pg/ml and the ft3 iii result was 9.2 pg/ml.The sample was repeated on an abbott instrument and the tsh, ft4 ii and ft3 iii results were in the normal ranges.It is not known if either patient was adversely affected.No adverse event was reported.The e601 analyzer serial number was (b)(4).

Manufacturer Narrative

It was clarified that the erroneous results were reported outside of the laboratory.

Manufacturer Narrative

The sample for patient 1 was submitted for investigation.The ft4 ii results were found to be above the reference range.A specific root cause could not be identified.Interference analysis was performed.No interfering factor was found in the investigated sample.

Manufacturer Narrative

The values of a given parameter generated by assays from different manufacturers may differ.This relates to the overall setup of the assay, the antibodies used and differences in reference methods and standardization.Further clarification of the differences observed between the different analyzers is not possible with available investigation methods.

• Brand Name: FT4, FREE THYROXINE
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 5316057
• MDR Text Key: 34051730
• Report Number: 1823260-2015-06087
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K961489
• 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,Followup
• Report Date: 03/28/2016

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 Catalogue Number: 06437281190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2015
• Initial Date FDA Received: 12/21/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/23/2015; 02/18/2016; 03/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1