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

Catalog Number	07027397190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
The customer questioned high results for multiple patients tested for either elecsys ft4 ii or 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 apr-2018 with the ft4 ii assay and may-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 ii.Refer to medwatch with (b)(6) for information on the ft4 iii results.Refer to attached data for the patient 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 (b)(4).
Additional Manufacturer Narrative
It was clarified that the high results from the roche method were reported outside of the laboratory.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS FT4 II ASSAY
• Common Device Name: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7691226
• Report Number: 1823260-2018-02344
• Device Sequence Number: 11423941
• Product Code: CEC
• UDI-Device Identifier: 04015630939725
• UDI-Public: 04015630939725
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K131244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 07027397190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 06/28/2018; 06/28/2018
• Initial Report FDA Received Date: 07/16/2018
• Supplement Report FDA Received Date: 08/13/2018; 11/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1