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 11/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

The customer received a questionable elecsys ft4 ii assay result on the roche diagnostics elecsys e170 modular analytics immunoassay analyzer (e 170) compared to the abbot architect.Of the data provide there was a discrepant elecsys ft4 ii and elecsys ft3 iii result on the on the e 170 with (b)(4) when compared to the abbott architect method for the same sample.This medwatch will cover the ft4 ii results.(b)(6).The initial ft4 ii result and the date tested were requested but not provided.The sample results were confirmed on the abbot architect on (b)(6) 2017.Based on the questionable results the sample was rerun after the ft4 ii reagent lot was changed and a new calibration was performed on (b)(6) 2017.The ft4 result was 1.39 ng/ml on the abbott architect method.On (b)(6) 2017 the ft4 ii result was 2.10 ng/ml with a repeat result of 2.14 ng/ml on the e 170.The ft3 result was 2.23 pg/ml on the abbott architect.On (b)(6) 2017 the ft3 iii result was 2.71 pg/ml on the e 170.The customer believes the elecsys ft4 ii and elecsys ft3 iii results on the architect are correct.It was asked but not known if the discrepant results were reported outside of the laboratory.There was no allegation of an adverse event.Additional information for further investigation was requested.

Manufacturer Narrative

A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.Based on review of the provided quality control data, a general reagent or analyzer issue was not suspected.

• 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: 7130835
• MDR Text Key: 95906041
• Report Number: 1823260-2017-03029
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: 02/07/2018

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: 265631
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 12/19/2017
• Supplement Dates Manufacturer Received: 11/30/2017
• Supplement Dates FDA Received: 02/07/2018
• 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: 79 YR