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 10/27/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation excluded an interfering factor.For the differences in the values generated with the different analyzers, assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used, differences in reference materials/methods, and the standardization methodology used.From the information provided, a general reagent issue can most likely be excluded.The investigation did not identify a reagent problem.

Event Description

The initial reporter received questionable elecsys tsh v2 and elecsys ft4 iii assay results for 2 patient samples tested on the customer's cobas e 801 module with serial number: (b)(4), the investigation site's cobas e 411 module with serial number: (b)(4) and the investigation site's cobas e 801 module with serial number: (b)(4).This medwatch is for the ft4 iii assay.Refer to medwatch with patient identifier: (b)(6) for the tsh v2 assay.The exact date of the event is unknown.The date the information was received was used as the date of the event.The initial results were not reported outside of the laboratory.The ft4 iii reagent lot number used at the customer site's e 801 was requested but not provided.The ft4 iii reagent lot number used at the investigation site's e 411 is 593219 with an expiration date of 31-dec-2022.The ft4 iii reagent lot number used at the investigation site's e 801 is 630888 with an expiration date of 31-may-2023.Refer to the attachment in the medwatch for the highlighted questionable results.

• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15916658
• MDR Text Key: 307901987
• Report Number: 1823260-2022-03863
• 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
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• 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: 07976836190
• Device Lot Number: ASKU, 593219, 630888
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2022
• 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