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 Consequences Or Impact To Patient (2199)

Event Date 01/25/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).

Event Description

The customer stated that they received erroneous results for one patient sample tested for elecsys ft3 iii (ft3) and the elecsys ft4 ii assay (ft4) on a roche diagnostics elecsys e170 modular analytics immunoassay analyzer (e170) and a cobas e 411 immunoassay analyzer (e411).It was asked, but it is not known if any erroneous results were reported outside of the laboratory.The customer stated that they had no other issues with questionable results except for this one patient sample.This medwatch will cover the ft4 assay.Patient identifier (b)(6) for information related to the ft3 assay.The patient sample was initially tested on the e170 analyzer and the results were 10.6 pg/ml for ft3 and 4.7 ng/dl for ft4.The sample was repeated on the e411 analyzer and the results were 4.9 pg/ml for ft3 and 2.1 ng/dl for ft4.The customer checked the primary tube and no clot or fibrin was found in the tube.The primary sample tube was centrifuged and dispensed into a secondary tube for re-testing on the e170 and e411 analyzers.When repeated again on the e170 analyzer, the sample resulted as 11.1 pg/ml for ft3 and 4.8 ng/dl for ft4.When repeated again on the e411 analyzer, the sample resulted as 5.0 pg/ml for ft3 and 2.0 ng/dl for ft4.The patient was not adversely affected.Controls were repeated the same day on both analyzers, but there was no change in control results.The e170 analyzer serial number was (b)(4).Ft4 reagent lot number 180429 was in use on this analyzer.The e411 analyzer serial number was (b)(4).Ft4 reagent lot number 180429 was in use on this analyzer.

Manufacturer Narrative

A specific root cause could not be determined based on the provided information.A sample from the patient was requested for investigation, but could not be provided.A general reagent issue could not be detected.Controls were found to be within specifications.To the observed differences in values between the e170 analyzer and the e411 analyzer for the ft4 and ft3 assays, a biological component may be present in the sample that may differently interact with the assay components.

• Brand Name: FT4, FREE THYROXINE
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• 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: 6328351
• MDR Text Key: 67443839
• Report Number: 1823260-2017-00304
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/14/2017

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: 180429
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2017
• Initial Date FDA Received: 02/14/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/14/2017
• 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