MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT4 III ASSAY; RADIOIMMUNOASSAY, FREE THYROXINE

Model Number FT4 G3

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation could not identify a product problem.The cause of the event could not be determined.This event occurred in (b)(6).(b)(4).

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with the elecsys ft4 iii assay on a cobas 8000 e 801 module.It was asked, but it is not known if any incorrect results were reported outside of the laboratory.Refer to the attachment for all patient data.The sample was initially tested on the customer's e 801 analyzer on (b)(6) 2019.The sample was repeated on a centaur analyzer.The sample was also provided for investigation, where it was tested on a second e 801 analyzer on (b)(6) 2019, a cobas e 411 immunoassay analyzer on (b)(6) 2019, and a cobas 8000 e 602 module on (b)(6) 2019.The serial number of the customer's e 801 analyzer is (b)(4).The serial number of the e 801 analyzer used for investigation is (b)(4).Ft4 reagent lot number 380330, with an expiration date of 31-dec-2019 was used on this analyzer.The serial number of the e 411 analyzer used for investigation is (b)(4).Ft4 reagent lot number 391521, with an expiration date of 29-feb-2020 was used on this analyzer.The serial number of the e 602 analyzer used for investigation is (b)(4).Ft4 reagent lot number 391521, with an expiration date of 29-feb-2020 was used on this analyzer.

• Brand Name: ELECSYS FT4 III ASSAY
• 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: 9233247
• MDR Text Key: 219553686
• Report Number: 1823260-2019-03848
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131244
• 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
• Report Date: 10/24/2019

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 Model Number: FT4 G3
• Device Catalogue Number: 07976887190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2019
• Initial Date FDA Received: 10/24/2019
• 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