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

Catalog Number	07027885190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).
Event or Problem Description
The customer stated that they received erroneous results for one patient sample tested with the elecsys t4 assay on a cobas 8000 e 801 module.The erroneous results were not reported outside of the laboratory.The sample was tested three times on the customer's e 801 analyzer, resulting with t4 values of 24.4 ug/dl, 24.9 ug/dl accompanied by a data flag, and 21.6 ug/dl.The sample was tested at another laboratory on a cobas 6000 e 601 module, resulting with a t4 value of 12.21 ug/dl.No adverse events were alleged to have occurred with the patient.The serial number of the customer's e 801 analyzer is (b)(4).The serial number of the e 601 analyzer used at the other laboratory was asked for, but not provided.
Additional Manufacturer Narrative
A sample was provided for investigation.An interfering factor against a component of the reagent was identified.This interference is addressed in the package insert.

• 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: 8018332
• Report Number: 1823260-2018-03894
• Device Sequence Number: 13710481
• Product Code: CDX
• UDI-Device Identifier: 04015630939800
• UDI-Public: 04015630939800
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2018

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 Expiration Date: 03/31/2019
• Device Catalogue Number: 07027885190
• Device Lot Number: 287093
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/09/2018
• Supplement Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 12/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 YR