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 Consequences Or Impact To Patient (2199)

Event Date 07/29/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The sample was requested for further investigation.(b)(6).

Event Description

The initial reporter questioned thyroid results for 1 patient sample tested on a cobas e801 module.The sample was submitted for investigation where discrepant elecsys tsh (tsh) and elecsys ft4 iii (ft4 iii) results were identified between the customer's e801 module, the architect method and an e801 module used at the investigation site.This medwatch will cover ft4 iii.Refer to medwatch with patient identifier (b)(6) for information on the tsh results with material number 07028091190 and medwatch with patient identifier (b)(6) for information on the tsh results with material 08443432190.No questionable results were reported outside of the laboratory.The serial number for the customer's e801 module was not provided.The e801 module used at the investigation site was (b)(4).The ft4 iii reagent used with the e801 module at the investigation site was 460793 with an expiration date of sep-2020.

Manufacturer Narrative

The sample was also tested at the investigation site on an e411 analyzer (serial number (b)(6)) for tsh (reagent lot 455423, exp.Oct-2020): the result was 4.65 uiu/ml.

Manufacturer Narrative

The sample was submitted for investigation.The customer's ft4 results were reproduced.Assays from different manufacturers, in this case abbott, can generate different results.This relates to the overall setups of the assays, the antibodies used, differences in reference materials and the standardization methodology used.The investigation did not identify a product problem.

• 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: 10439872
• MDR Text Key: 204224614
• Report Number: 1823260-2020-02074
• 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,Followup
• Report Date: 10/29/2020

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: 07/29/2020
• Initial Date FDA Received: 08/21/2020
• Supplement Dates Manufacturer Received: 07/29/2020; 07/29/2020
• Supplement Dates FDA Received: 09/14/2020; 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1