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

Model Number FT4 G3

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/16/2022

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with elecsys ft3 iii (ft3), elecsys ft3 iii ver.2 (ft3 v2), and the elecsys ft4 iii assay on two cobas 8000 e 801 modules.The values measured at the customer site 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 and refer to the medwatch with patient identifier (b)(6) for information related to the ft3 v2 assay.The sample was initially tested on the customer's e 801 analyzer on (b)(6) 2022 (run 1).The sample was refrigerated for 6 days and re-measured on the customer's e 801 analyzer on (b)(6) 2022 (run 2 and run 3).The customer repeated the sample on an abbott architect analyzer.The sample was provided for investigation, where it was tested on a second e 801 analyzer on (b)(6) 2022.The sample was also repeated on a siemens centaur analyzer.The serial number of the customer's e 801 analyzer is (b)(4).The ft4 reagent lot number and expiration date used on this analyzer were requested, but not provided.The serial number of the e 801 analyzer used for investigation is (b)(4).Ft4 reagent lot number 572941, with an expiration date of 30-sep-2022 was used on this analyzer.

Manufacturer Narrative

Assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used and, differences in reference materials/methods, and differences in the standardization methodology used.The investigation could not identify a product problem.The cause of the event could not be determined.

Manufacturer Narrative

The correct ft3 reference range for the abbott architect is 1.68 - 3.67 pg/ml.

• Brand Name: ELECSYS FT4 III
• 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: 13838835
• MDR Text Key: 293449541
• Report Number: 1823260-2022-00781
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2022

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, 572941
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2022
• Initial Date FDA Received: 03/21/2022
• Supplement Dates Manufacturer Received: 03/19/2022
• Supplement Dates FDA Received: 04/11/2022
• 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
• Patient Sequence Number: 1
• Treatment: THYRADIN (LEVOTHYROXINE SODIUM HYDRATE).