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 11/14/2022

Event Type  malfunction  

Manufacturer Narrative

Patient sample: (b)(6) was requested for further investigation.This patient sample will be investigated for possible interfering factors.

Event Description

The initial reporter received questionable elecsys tsh ver.2 assay, elecsys ft4 iii assay, elecsys ft3 iii and elecsys ft3 iii ver.2 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 ft3 iii assay; medwatch with patient identifier: (b)(6) for the ft3 iii v2 assay; 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 patient samples were sent to an investigation site that uses an e 411 and e 801.It was also sent to an outsourced laboratory that uses an abbott architect.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.

Manufacturer Narrative

The qc and calibration generated at the investigation site were within specifications.The cause of the event could not be determined as the patient samples were not available for further investigation.Product labeling states: "for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." medwatch field b6 - relevant test/laboratory data was updated.

• 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: 15996810
• MDR Text Key: 308250413
• Report Number: 1823260-2022-04051
• 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: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• 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: 02/13/2023
• 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