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 08/31/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of questionable results for 2 patients tested for free thyroxine (ft4) and thyrotropin (tsh).Based on the available data, the results for 1 patient were erroneous.It is not known if erroneous results were reported outside of the laboratory.The date of event was not provided.No patient information was provided.This medwatch will cover ft4.Refer to medwatch with a1 patient identifier (b)(6) for information on the tsh erroneous results.The initial ft4 result on the e601 analyzer was 1.97 ng/dl.The patient's initial tsh result on the e601 analyzer was 0.474 miu/ml.The sample was repeated on a siemens centaur analyzer and the ft4 result was 1.68 ng/dl.The sample was repeated on a siemens dimension analyzer and the tsh result was 0.311 miu/ml.The sample was also repeated on an abbott analyzer and the ft4 result was 1.54 ng/dl and the tsh result was 0.2921 miu/ml.It is not known if the patient was adversely affected.No adverse event was reported.The e 601 analyzer serial number was (b)(6).

Manufacturer Narrative

It was noted that the customer thinks the discrepant results may be caused by amiodanora hypothyroidism.The customer believes the results are due to an interference with trangorex.

Manufacturer Narrative

A specific root cause could not be identified.The patient sample was not available to complete the investigation.

• 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: 5078734
• MDR Text Key: 25885292
• Report Number: 1823260-2015-04168
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• 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: 183473
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 08/31/2015
• 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