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

Catalog Number 07976836190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Pt data - (b)(6).

Event Description

The customer received questionable thyroid results for one patient sample from cobas 8000 cobas e 602 module serial number (b)(4).The sample was sent for testing on a centaur analyzer and for investigation on a cobas 8000 cobas e 602 module and a cobas e 411 immunoassay analyzer.Refer to the attachment to the medwatch for all patient data.This medwatch is for elecsys ft4 iii.Refer to the medwatches with patient identifiers (b)(6) for the elecsys ft3 iii assay and (b)(6) for the elecsys tsh assay.The erroneous results were reported outside of the laboratory.There was no allegation of an adverse event.

Manufacturer Narrative

The patient sample was submitted for investigation.An interfering factor against the ruthenium label of the assay was identified in the sample.The rarely occurring event of this interfering factor is covered by a disclaimer in the section limitation ¿ interference in the method sheets of all applicable products: 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.

• Brand Name: ELECSYS FT4 III ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7970774
• MDR Text Key: 123961269
• Report Number: 1823260-2018-03704
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• PMA/PMN Number: K131244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07976836190
• Device Lot Number: 315901
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMIODARONE; THYRADIN
• Patient Age: 73 YR