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

Model Number FT4 G3

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter complained of discrepant results for 1 patient sample tested for elecsys ft4 iii (ft4 iii) on a cobas e 411 immunoassay analyzer compared to an unspecified clia method.The sample was submitted for investigation where discrepant ft4 iii results were also generated on an e411 analyzer used at the investigation site.Refer to attached data for the patient results.No questionable results were reported outside of the laboratory.The customer¿s e411 analyzer serial number was (b)(4).The e411 analyzer serial number at the investigation site was (b)(4).The ft4 iii reagent lot number used at the investigation site was (b)(4) with an expiration date of may-2021.

Manufacturer Narrative

Based on the information provided, a general reagent issue can be excluded.Assays from different manufacturers, in this case abbott and wako, 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: 11064002
• MDR Text Key: 234406333
• Report Number: 1823260-2020-03349
• 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: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• 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: 459257
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 33 YR