MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT4 II ASSAY; RADIOIMMUNOASSAY, FREE THYROXINE

Catalog Number	07027397190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event occurred in: (b)(6).
Event or Problem Description
The customer complained of questionable thyroid results for 2 patient samples tested on a cobas 8000 e 801 module and a cobas 8000 e 601 compared to a siemens centaur.From the data provided, a reportable malfunction was provided for elecsys tsh assay (tsh), elecsys t3 (t3), elecsys t4 assay (t4), and elecsys ft4 ii assay (ft4 ii).Medwatches related to this issue included patient identifiers (b)(6).The erroneous results were not released outside of the laboratory.There was no allegation of an adverse event.The cobas e801 serial number was (b)(4).The cobas e601 serial number was requested but was not provided.The investigation is currently ongoing.
Additional Manufacturer Narrative
The customer provided samples for each patient for further investigation.The samples were tested on a system without a pre-wash (cobas e411), compared to systems with a pre-wash (cobas e601, cobas e801).Initial investigation of the sample confirmed the sample contained an immunoglobulin that reacts with the reagent which affects the sample results.Upon further investigation of the patient sample, an interferent against a component of the reagent was confirmed.This interference is documented in product labeling.Product labeling states "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.".
Additional Manufacturer Narrative
For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination, and other findings.No product problem could be found.

• 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: 7702327
• Report Number: 1823260-2018-02393
• Device Sequence Number: 2643813
• Product Code: CEC
• UDI-Device Identifier: 04015630939725
• UDI-Public: 04015630939725
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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,Followup,Followup
• Report Date (Section B): 10/09/2018

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
• Initial Date Received by Manufacturer: 06/26/2018
• Supplement Date Received by Manufacturer: 06/26/2018; 06/26/2018
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 09/17/2018; 10/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR