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

Catalog Number	07027885190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event occurred in: (b)(6).
Event or Problem Description
The customer complained of questionable results for multiple tests for 1 patient tested on a cobas 8000 e 801 module compared to an advia centauro.From the data provided, a reportable malfunction was provided for elecsys ft3 iii, elecsys prolactin assay, elecsys t3, elecsys t4 assay, elecsys testosterone ii assay, and elecsys estradiol iii assay.The customer suspect there is an interference affecting the patient sample.This medwatch will cover the t4 assay.Please refer to the following medwatches with the following patient identifiers for information related to each other affected assay: (b)(6).The discrepant results are highlighted.It was unknown if the erroneous results were reported outside of the laboratory.There was no allegation of an adverse event.The investigation is currently ongoing.
Additional Manufacturer Narrative
A sample was provided for investigation.Due to low sample volume (~200 ul) only limited testing could be performed.The results of the testing are consistent with an antibody against a component of the reagent.This interring factor is addressed in the product labeling.
Additional Manufacturer Narrative
Another aliquot of the patient sample was provided for further investigation.The results obtained by the customer were reproduced.An interferent against a component of the reagent was confirmed.This interference is covered in product labeling.From the information and data provided, a general reagent issue most likely can be excluded.

• 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: 8059180
• Report Number: 1823260-2018-04173
• Device Sequence Number: 1902511
• Product Code: CDX
• UDI-Device Identifier: 04015630939800
• UDI-Public: 04015630939800
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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,Followup
• Report Date (Section B): 01/22/2019

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 Expiration Date: 03/31/2019
• Device Catalogue Number: 07027885190
• Device Lot Number: 28709300
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/17/2018
• Supplement Date Received by Manufacturer: 10/17/2018; 10/17/2018
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 01/03/2019; 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 17 YR