MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS T4 ASSAY; RADIOIMMUNOASSAY, TOTAL THYROXINE

Catalog Number	ASKU
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
The customer received questionable thyroid results for one patient sample from cobas 8000 cobas e 602 module serial number (b)(4) when compared to the results from an abbott architect.The results from the cobas e602 did not correlate with patient symptom and an interference was suspected.This medwatch is for elecsys t4 assay.Refer to the following medwatch with patient identifier for the other assays involved: elecsys tsh assay=(b)(6).Elecsys t3 assay=(b)(6).Elecsys ft3=(b)(6).Elecsys ft4 assay=(b)(6).The erroneous results were reported outside of the laboratory.There was no allegation of an adverse event.
Additional Manufacturer Narrative
The customer provided samples for investigation.The result difference of t3 and t4 was cause by an interfering factor to a component of the reagent.This type of interfering factor is addressed in the respective product labeling.

• Brand Name: ELECSYS T4 ASSAY
• Common Device Name: RADIOIMMUNOASSAY, TOTAL THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7965362
• Report Number: 1823260-2018-03669
• Device Sequence Number: 1409368
• Product Code: CDX
• UDI-Device Identifier: 04015630912728
• UDI-Public: 04015630912728
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K961490
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2019

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: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 10/15/2018
• Supplement Report FDA Received Date: 01/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR