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

Catalog Number ASKU

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer questioned high results for multiple patients tested for both elecsys ft4 ii and elecsys ft4 iii on a cobas 8000 e 602 module.The customer thinks the roche results are falsely elevated and sent all patient results above the reference range to an external laboratory for testing using an unspecified method.The customer provided data generated between (b)(6) 2018 with the ft4 ii assay and (b)(6) 2018 with the ft4 iii assay for 67 patient samples.Based on the data provided, the results for 64 patient samples were discrepant when tested for ft4 ii or ft4 iii.This medwatch will cover ft4 iii.Refer to medwatch with patient identifier (b)(6) for information on the ft4 ii results.It is not clear if the high results were reported outside of the laboratory.There was no allegation that an adverse event occurred.The e602 module serial number was (b)(4).

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.

Manufacturer Narrative

It was clarified that the high results from the roche method were reported outside of the laboratory.

• 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: 7691230
• MDR Text Key: 114434373
• Report Number: 1823260-2018-02345
• 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,Followup
• Report Date: 11/06/2018

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: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/28/2018
• Initial Date FDA Received: 07/16/2018
• Supplement Dates Manufacturer Received: 06/28/2018; 06/28/2018
• Supplement Dates FDA Received: 08/13/2018; 11/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1