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 reported that they received erroneous results for one patient sample tested for free thyroxine (ft4).The date of the event was asked for, but not provided.The sample was initially tested at the customer site on an e602 analyzer.During investigations, the patient sample was tested on a centaur analyzer, a cobas 8000 analyzer, and an e411 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 e602 analyzer serial number used at the customer site was asked for, but not provided.The cobas 8000 analyzer used for investigation purposes was serial number (b)(4).The ft4 reagent lot number used on this analyzer was 183473, with an expiration date of january 2016.The e411 analyzer used for investigation purposes was serial number (b)(4).The ft4 reagent lot number used on this analyzer was 184927, with an expiration date of march 2016.

Manufacturer Narrative

A specific root cause could not be determined based on the provided information.There was no additional sample volume available 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.

• 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: 5223531
• MDR Text Key: 31185672
• Report Number: 1823260-2015-04542
• 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

• 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: 10/29/2015
• Initial Date FDA Received: 11/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/02/2015
• 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