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	04/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
The customer received questionable thyroid results for two samples from one patient from the cobas 8000 e 801 module.The sample was then tested on an architect analyzer and submitted for investigation where it was tested on a cobas 8000 e 801 module, cobas 6000 e602 module, and a cobas e 411 immunoassay analyzer.Refer to the medwatch with the following patient identifiers: (b)(6) elecsys tsh assay; (b)(6) elecsys ft4 assay; (b)(6) elecsys ft3 iii.The erroneous results were reported outside of the laboratory.There was no allegation of an adverse event.The investigation did not identify a product problem.The cause of the event could not be determined as no sample was available for further investigation.From the information provided, a general reagent issue could most likely be excluded.

• 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: 7991552
• Report Number: 1823260-2018-03787
• Device Sequence Number: 1682535
• Product Code: CEC
• UDI-Device Identifier: 04015630939725
• UDI-Public: 04015630939725
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 10/22/2018

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 10/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR