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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2022

Event Type  malfunction  

Event Description

The initial reporter received questionable elecsys ft3 iii, elecsys ft4 iii, and elecsys tsh assay results for three patient samples with the cobas e 801 module serial number (b)(4).The customer reported the ft4 results to a physician who asked for re-measurement of the samples.The samples were sent for an investigation and were tested on a cobas e801 module, cobas e 411 immunoassay analyzer, and a siemens centaur analyzer.The investigation site e801 module serial number was (b)(4).The e411 serial number was (b)(4).The ft4 reagent used at the investigation site on the e801 was lot number 541093 with an expiration date of 31-may-2022.The ft4 reagent used at the investigation site on the e411 was lot number 579081 with an expiration date of 31-oct-2022.This medwatch is for ft4.Refer to the medwatch with patient identifier (b)(6) for the ft3 and (b)(6) for the tsh assay.

Manufacturer Narrative

The investigation is ongoing.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.For all samples, the differences in the ft4 values generated with the assays from roche diagnostics and siemens are most likely due to differences of the setups of the assays, the antibodies used, and differences of the standardization materials and procedures used.From the information provided, a general reagent issue could be excluded.

• 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: 13567771
• MDR Text Key: 292582252
• Report Number: 1823260-2022-00451
• 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: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2022
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2022
• 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