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 08/20/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer received questionable thyroid results for one patient sample from cobas e411 analyzer serial number (b)(4).The sample was submitted for investigation and was tested on a cobas e411 analyzer and a centaur analyzer.The results for thyrotropin (tsh), free thyroxine (ft4), and free triiodothyronine (ft3) were discrepant.Refer to the medwatch with (b)(6) for the other assays.Information concerning if any erroneous result was reported outside the laboratory was requested, but was not provided.No adverse event was reported.A specific root cause could not be identified as insufficient sample material remained for further investigation.From the information provided, a general reagent issue was not likely.When comparing results generated by different types of analyzers, variances can be expected due to the different setups of all assays, the antibodies used and the variances in reference methods.For thyroid parameters, the patient's age, gender, and other characteristics should be considered when analyzing results.

• 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: 5085702
• MDR Text Key: 26115118
• Report Number: 1823260-2015-04189
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 09/17/2015

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 Expiration Date: 03/30/2016
• Device Catalogue Number: 06437281190
• Device Lot Number: 184927
• 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: 09/17/2015
• 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: 031 YR