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

Catalog Number 07976836190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer initially complained of discrepant results between elecsys ft4 ii assay (ft4 ii) and elecsys ft4 iii (ft4 iii) for 2 patient samples tested on a cobas 6000 e 601 module.The customer reported the results outside of the laboratory and requested for the samples to be investigated.The samples were submitted for investigation where discrepant results were identified for ft4 ii, ft4 iii, elecsys ft3 iii (ft3 iii) and elecsys tsh assay (tsh) between the customer's e601 module, the centaur method, a cobas e801 module used at the investigation site and a cobas e 411 immunoassay analyzer used at the investigation site.Patient identifiers: (b)(6).Refer to attached data for the patient results.There was no allegation that an adverse event occurred.The customer's e601 module serial number was (b)(4).The e801 module serial number was (b)(4).The e411 analyzer serial number was (b)(4).The ft4 iii reagent lot number used at the investigation site was 304692 with an expiration date of jan-2019.

Manufacturer Narrative

Based on the available data, a general reagent issue could be excluded.There was not enough sample volume left to complete the investigation.The investigation was unable to find a definitive root cause.

• 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: 7578343
• MDR Text Key: 110869331
• Report Number: 1823260-2018-01782
• 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: 06/14/2018

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: 07976836190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/21/2018
• Initial Date FDA Received: 06/07/2018
• Supplement Dates Manufacturer Received: 05/21/2018
• Supplement Dates FDA Received: 06/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1