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 Known Impact Or Consequence To Patient (2692)

Event Date 10/27/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer questioned results from 1 patient sample tested for thyrotropin (tsh), free thyroxine (ft4 ii) and ft3 - free triiodothyronine (ft3 iii).The customer did not provide any of the questionable results for the patient from the customer site.The customer provided the patient sample for investigation.During the investigation of the provided sample, erroneous ft4 ii results were identified between a centaur analyzer and a cobas 8000 instrument used at the investigation site.Erroneous ft3 iii results were identified between the centaur analyzer, the cobas 8000 instrument and an e411 analyzer used at the investigation site.It is not known if erroneous results were reported outside of the laboratory.This medwatch will cover ft4 ii.No adverse event was reported.The cobas 8000 instrument serial number was (b)(4).

Manufacturer Narrative

The customer has provided the patient results from the customer site.Based on the data provided, additional erroneous ft4 ii results were identified between the customer's (b)(4) analyzer and a centaur analyzer.Refer to the attached data for the updated patient results from the customer site and other relevant tests from the customer site.Lot number and expiration date were updated to reflect the customer's information.The ft4ii reagent lot number used at the investigation site with the cobas 8000 system was 183473 with an expiration date of 01/31/2016.The ft4ii reagent lot number used at the investigation site with the (b)(4) analyzer was 184927 with an expiration date of 03/31/2016.

Manufacturer Narrative

The sample was submitted for investigation.Investigation confirmed the presence of a streptavidin interfering factor.This specific interference is addressed in product labeling.

Manufacturer Narrative

Further investigation determined that an interfering factor is present but the interference is not against the streptavidin component of the reagent.The interfering factor 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: 5220637
• MDR Text Key: 31031945
• Report Number: 1823260-2015-04531
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/02/2016

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 Expiration Date: 01/31/2016
• Device Catalogue Number: 06437281190
• Device Lot Number: 183473
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 10/27/2015
• Initial Date FDA Received: 11/12/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 11/18/2015; 12/16/2015; 02/02/2016
• 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