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

Catalog Number 06437281160

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

The customer complained of questionable thyroid results for 1 patient sample on a cobas 6000 e 601 module.Of the data provided, discrepant results were identified for elecsys t3, elecsys ft3 iii, elecsys t4, and elecsys ft4 ii assay on the e601 module and a cobas 6000 e 801 module compared to the bayer centaur method.The erroneous results were reported outside of the laboratory.This medwatch will cover ft4 ii.Refer to medwatch with patient identifier (b)(6) for information on the t3 results, medwatch with patient identifier (b)(6) for information on the ft3 iii results, and medwatch with patient identifier (b)(6) for information on the t4 results.There was no allegation of an adverse event.The customer's cobas e601 serial number was (b)(4).The customer's cobas e801 serial number was (b)(4).The ft3 iii reagent lot number used on the cobas e601 was 303235.The t3, t4, and ft4 ii reagent lot numbers used on the cobas e601 were not provided.The t3 reagent lot number used on the cobas e801 was 291614.The ft3 iii reagent lot number used on the cobas e801 was 314824.The t4 reagent lot number used on the cobas e801 was 287093.The ft4 ii reagent lot number used on the cobas e801 was 303203.The reagent expiration dates were not provided.

Manufacturer Narrative

A patient sample was provided for investigation.The investigation found an interfering factor against a component of the reagent.These interferences are addressed in the product labeling.

• Brand Name: ELECSYS FT4 II ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8161633
• MDR Text Key: 130477131
• Report Number: 1823260-2018-04857
• 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: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06437281160
• Device Lot Number: 30320300
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1