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

Catalog Number 06437281190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer questioned thyroid results for 1 patient sample tested on an unspecified roche instrument and submitted the sample for investigation.Based on the data provided, discrepant results were identified for elecsys ft4 ii assay (ft4 ii) and tsh between the customer's unknown system, a cobas 8000 e 602 module used at the investigation site and the siemens centaur method.It is not known if the initial results from the customer site were reported outside of the laboratory.This medwatch will cover ft4 ii.Refer to medwatch with patient identifier (b)(6) for information on the tsh results.There was no allegation that an adverse event occurred.The instrument type and serial number used at the customer site was not provided.The e602 module serial number used at the investigation site was (b)(4).The ft4 ii reagent lot number used at the investigation site was 315901 with an expiration date of may-2019.

Manufacturer Narrative

There was not enough sample material remaining to complete the investigation.Based on the data provided, a general reagent issue can be excluded.Assays from different manufacturers, in this case siemens, can generate different results.The investigation was unable to find a definitive root cause.

• Brand Name: FT4, FREE THYROXINE
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7818063
• MDR Text Key: 118563191
• Report Number: 1823260-2018-02864
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 04015630930920
• UDI-Public: 4015630930920
• Combination Product (y/n): N
• PMA/PMN Number: K961489
• 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: 09/07/2018

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: 06437281190
• Device Lot Number: 303235
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/08/2018
• Initial Date FDA Received: 08/27/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1