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

Catalog Number 06437281190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer complained of erroneous results for 1 patient tested for thyrotropin (tsh), triiodothyronine (t3), free triiodothyronine (ft3), thyroxine (t4), and free thyroxine (ft4).The erroneous results were reported outside of the laboratory.This medwatch will cover ft4.Refer to medwatch with patient identifier (b)(6) for information on the tsh erroneous results, medwatch with patient identifier (b)(6) for information on the t3 erroneous results, medwatch with patient identifier (b)(6) for information on the ft3 erroneous results, and medwatch with patient identifier (b)(6) for information on the t4 erroneous results.On (b)(6) 2015, the physician complained that thyroid results obtained on an e602 analyzer for this patient did not correspond to his clinical condition.On (b)(6) 2015, the patient had a tsh result of 0.93 uiu/ml, a t3 result of 160.4 ng/dl, an ft3 result of 17.98 pg/ml, a t4 result > 24.86 ug/dl and an ft4 result >7.77 ng/dl.This sample was diluted 1:2 by using polyethylene-glycol (peg) precipitation and the tsh result was 2.68 uiu/ml, the t3 result was 185.22 ng/dl, ft3 result was 3.62 pg/ml, t4 result was 11.12 ug/dl and ft4 result was 2.76 ng/dl.On (b)(6) 2015, a new sample was obtained and tested on the e602 analyzer.The initial tsh result was 0.92 uiu/ml, the t3 result was 153.3 ng/dl, the ft3 result was 15.83 pg/ml, the t4 result was >24.86 ug/dl and the ft4 result was >7.77 ng/dl.The sample was repeated on an architect instrument and the tsh result was 2.6519 uiu/ml, the t3 result was 52.36 ng/dl, the ft3 result was 1.38 pg/ml, the t4 result was 8.9 ug/dl and the ft4 result was 1.09 ng/dl.On (b)(6) 2015, an additional sample was tested on the e602 analyzer.The tsh result was 1.000 uiu/ml, the t3 result was 169.2 ng/dl, the ft3 result was 16.3 pg/ml, the t4 result was >24.86 ug/dl and the ft4 result was >7.77 ng/dl.No adverse event occurred.The e602 analyzer serial number was (b)(4).On (b)(6) 2015, the application specialist visited the site and the internal quality controls were acceptable.

Manufacturer Narrative

The expiration date for ft4 was provided as 01/2016.

Manufacturer Narrative

An additional sample was obtained for this patient on (b)(6) 2015.The patient was tested on the e602 analyzer and the tsh result was 1.45 uiu/ml, the t3 result was 280.2 ng/dl, the ft3 result was 15.3 pg/ml, the t4 result was >24.86 ug/dl, and the ft4 result was 7.77 ng/dl.The sample was submitted for investigation.Investigation confirmed the presence of a streptavidin interfering factor.This specific interference is addressed in product labeling.

• Brand Name: FT4, FREE THYROXINE
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• 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: 5144159
• MDR Text Key: 28044297
• Report Number: 1823260-2015-04313
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: ASKU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Followup,Followup
• Report Date: 11/09/2015

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: 186318
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/21/2015; 11/09/2015
• 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
• Patient Age: 063 YR