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 09/02/2015

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) and free triiodothyronine (ft3).The customer provided the sample for investigation.Of the data provided, erroneous ft4 and ft3 results were identified between the customer's e601 analyzer, an architect analyzer, an e 170 analyzer used at the investigation site 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.Refer to medwatch with patient identifier (b)(6) for information on the ft3 erroneous results.Refer to the attached data for patient results.No adverse event was reported.The e 170 analyzer serial number was (b)(4).The e411 analyzer serial number was (b)(4).The ft4 reagent lot number used at the investigation site was 180539 with an expiration date of 10/31/2015.The serial number for the customer's e601 analyzer was (b)(4).

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.

• 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: 5080823
• MDR Text Key: 26120261
• Report Number: 1823260-2015-04175
• 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: 09/30/2015

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: ASKU
• 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: 09/16/2015
• 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: 064 YR