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	08/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).Pt results: (b)(6).
Event or Problem Description
The customer questioned results for 1 patient sample tested for elecsys ft3 iii (ft3 iii), elecsys ft4 ii (ft4 ii) and elecsys tsh (tsh) on a cobas e801 module.Based on the data provided, discrepant ft4 ii results were identified between the customer's e801 module, the centaur method and an e801 module used at the investigation site.The initial ft4 ii result from the customer site was reported outside of the laboratory.Refer to attached data for the patient results.There was no allegation that an adverse event occurred.The serial number for the customer's e801 module was not provided.The e801 module serial number used at the investigation site was (b)(4).The ft4 ii reagent lot number used at the investigation site was 303203 with an expiration date of apr-2019.From the information provided, a general reagent issue can be excluded.Assays from different manufacturers, in this case siemens, can generate different results.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: 7901325
• Report Number: 1823260-2018-03259
• Device Sequence Number: 1434343
• 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): 09/24/2018

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 09/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1