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

Catalog Number	06437281160
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
The customer received questionable elecsys tsh assay and elecsys ft4 ii assay results for one patient from cobas 6000 e 601 module serial number (b)(4) and from a cobas 8000 e 801 module compared to the result from an abbott architect.This medwatch is for ft4.Refer to the medwatch with patient identifier (b)(6) for the tsh assay.The results were reported outside of the laboratory but the patient's endocrinologist did not believe the tsh result.There was no allegation of an adverse event.The serial number of the cobas 8000 e 801 module was requested but was not provided.
Additional Manufacturer Narrative
Sample from the patient was submitted for investigation.No interfering factor was found.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: 7886685
• Report Number: 1823260-2018-03183
• Device Sequence Number: 2725935
• Product Code: CEC
• UDI-Device Identifier: 04015630934232
• UDI-Public: 04015630934232
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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
• Report Date (Section B): 10/05/2018

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: 06437281160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/31/2018
• Supplement Date Received by Manufacturer: 08/31/2018
• Initial Report FDA Received Date: 09/18/2018
• Supplement Report FDA Received Date: 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ELTROXIN