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 11/13/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).It was stated that the patient is in his 50s.

Event Description

The customer reported that they received questionable results for one patient sample tested for thyrotropin (tsh), free triiodothyronine (ft3), free thyroxine (ft4), and thyroxine (t4).Of the mentioned tests, the sample had erroneous results for ft3 and ft4.The date of the event was asked for, but not provided.This medwatch will cover ft4.Refer to the medwatch with patient identifier (b)(4) for information referring to ft3.The sample was initially tested at the customer site on an e601 analyzer.During investigations, the patient sample was tested on a modular pe analyzer and a centaur analyzer.Refer to the attachment for the specific patient result values.It was asked, but it is unknown which patient results, if any, were reported outside of the laboratory.It was asked, but it is not known if the patient was adversely affected.No adverse events were alleged.The e601 analyzer serial number used at the customer site was asked for, but not provided.

Manufacturer Narrative

A specific root cause could not be determined as there was not adequate sample volume remaining for further investigation.A general reagent issue can most likely be excluded.Given the different setups of all assays, the antibodies used and the variances in reference methods, differences in values may occur when comparing these assays from different vendors.In addition, the values of all thyroid parameters vary in function of age, gender and other population characteristics.

• 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: 5242454
• MDR Text Key: 31811957
• Report Number: 1823260-2015-04613
• 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
• Type of Report: Initial,Followup
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2015
• 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: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 11/13/2015
• 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