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

Catalog Number 07027397190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).

Event Description

The customer questioned thyroid results for 1 patient sample tested for elecsys ft4 ii (ft4 ii), elecsys ft3 iii (ft3 iii) and elecsys tsh (tsh) on a cobas e 801 module.The patient sample was submitted for investigation where discrepant results were identified for ft4 ii, ft3 iii and tsh between the customer's e801 module, the centaur 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.It is not known if any incorrect 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 ft3 iii erroneous results and medwatch with a1 patient identifier (b)(6) for information on the tsh erroneous results.Refer to attached data for the patient results.There was no allegation that an adverse event occurred.The serial number for the customer's e801 module was not provided.The patient samples were also treated and underwent polyethylene glycol (peg) testing.Refer to attached data for these results.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 ii reagent lot number used with the e602 module was 225129 with an expiration date of 30-jul-2018.The ft4 ii reagent lot number used with the e411 analyzer was 288197 with an expiration date of 31-dec-2018.The ft4 ii reagent lot number used with the e801 module at the investigation site was 265662 with an expiration date of 30-nov-2018.

Manufacturer Narrative

Upon further investigation of the patient sample, an interferent against a component of the reagent was confirmed.This caused the high ft4 ii and ft3 iii results.This interference is covered in 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: 7566340
• MDR Text Key: 110175250
• Report Number: 1823260-2018-01724
• 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: 06/13/2018

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 Catalogue Number: 07027397190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/16/2018
• Initial Date FDA Received: 06/04/2018
• Supplement Dates Manufacturer Received: 05/16/2018
• Supplement Dates FDA Received: 06/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1