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 01/08/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with elecsys ft3 iii and the elecsys ft4 iii assay on a cobas 8000 e 801 module and a second e 801 analyzer, a cobas 8000 e 602 module, and a cobas e 411 immunoassay analyzer used for investigation.The results measured by the customer were reported outside of the laboratory to a physician.This medwatch will apply to the ft4 assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the ft3 assay.Refer to the attachment for all patient data.The sample was initially tested on the customer's e 801 analyzer on (b)(6) 2020.The sample was repeated on a centaur analyzer.The sample was provided for investigation, where it was tested on a second e 801 analyzer and an e411 analyzer on (b)(6) 2020 and it was tested on an e 602 analyzer on (b)(6) 2020.The customer's e 801 analyzer serial number is (b)(4).The serial number of the e 602 analyzer used for investigation is 1286-07.Ft4 reagent lot number 410248, with an expiration date of 31-may-2020 was used on this analyzer.The serial number of the e411 analyzer used for investigation is (b)(4).Ft4 reagent lot number 410248, with an expiration date of 31-may-2020 was used on this analyzer.The serial number of the e 801 analyzer used for investigation is (b)(4).Ft4 reagent lot number 432844, with an expiration date of 30-sep-2020 was used on this analyzer.

Manufacturer Narrative

Upon further investigation of the patient sample, it was determined the sample did not contain any interferents to components of the ft4 assay.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS FT4 III ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9694215
• MDR Text Key: 213498679
• Report Number: 1823260-2020-00377
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• PMA/PMN Number: K131244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/16/2020
• Initial Date FDA Received: 02/11/2020
• Supplement Dates Manufacturer Received: 01/16/2020
• Supplement Dates FDA Received: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1