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

Model Number FT4 G3

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The e602 module serial number was (b)(4).The e411 analyzer serial number was (b)(4).The e801 module serial number used at the investigation site was (b)(4).The ft4 iii reagent lot number used with the e602 module and the e411 analyzer was 391521 with an expiration date of feb-2020.The ft4 iii reagent lot number used with the e801 module at the investigation site was 380330 with an expiration date of dec-2019.

Event Description

The initial reporter questioned thyroid results for 1 patient sample tested for elecsys ft3 iii (ft3 iii), elecsys tsh (tsh), and elecsys ft4 iii (ft4 iii) between a cobas e 801 module and the accuraseed method.The customer's results were reported outside of the laboratory.The patient sample was submitted for investigation where discrepant results were identified for ft3 iii, tsh, ft4 iii and ft4 ii between the customer's e801 module, the architect method, the accuraseed method, an e801 module used at the investigation site, a cobas 8000 e 602 module used at the investigation site and a cobas e 411 immunoassay analyzer used at the investigation site.This medwatch will cover ft4 iii.Refer to medwatch with patient identifier (b)(6) for information on the ft4 ii results, medwatch with patient identifier (b)(6) for information on the ft3 iii erroneous results and medwatch with patient identifier (b)(6) for information on the tsh results.There was no allegation that an adverse event occurred.The serial number for the customer's e801 module was (b)(4).

Manufacturer Narrative

Sample from the patient was provided for further investigation.Further investigation of the sample confirmed the sample contained an immunoglobulin that reacts with the reagent which affects the sample results.This is covered in product labeling.

• 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: 8780081
• MDR Text Key: 150758920
• Report Number: 1823260-2019-02520
• 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: 08/14/2019

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/20/2019
• Initial Date FDA Received: 07/11/2019
• Supplement Dates Manufacturer Received: 06/20/2019
• Supplement Dates FDA Received: 08/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THYRADIN; THYRADIN
• Patient Age: 17 YR