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

Catalog Number ASKU

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/29/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of erroneous high results for 2 patient samples tested for elecsys ft3 iii (ft3 iii) on a cobas 8000 e 602 module compared to the abbott architect method.Based on the data provided, erroneous tsh results were also identified for patient 1 and erroneous ft4 results were also identified for patient 2.The erroneous results were not reported outside of the laboratory.This medwatch will cover ft4.(b)(4).Refer to attached data for patient results.There was no allegation that an adverse event occurred.The e602 module serial number was not provided.

Manufacturer Narrative

Patient 2 was tested on the abbott architect system on (b)(6) 2017 and not (b)(6) 2017 as stated in the initial report.

Manufacturer Narrative

The customer provided data for an additional patient sample (patient 3) with erroneous tsh and ft4 results compared to the architect method.No information was provided concerning if an erroneous result was reported outside the laboratory or if the patient was adversely affected.

Manufacturer Narrative

A specific root cause was not identified for the discrepant ft4 ii results for patient 2.Further investigation of patient sample 2 did not identify an interference when testing with the ft4 ii assay.Ft4 ii results generated with different types of analyzers can produced different results.This relates to the overall setup of each assay, the antibodies used and differences in reference materials/methods and the standardization methodology used.Further investigation of patient sample 3 confirmed an interferent against a component of the reagent for the ft4 ii assay.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.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.".

• Brand Name: ELECSYS FT4 ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6847943
• MDR Text Key: 85644042
• Report Number: 1823260-2017-01924
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: ASKU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/17/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2017
• Initial Date FDA Received: 09/07/2017
• Supplement Dates Manufacturer Received: 08/17/2017; 08/17/2017; 08/17/2017
• Supplement Dates FDA Received: 09/11/2017; 10/23/2017; 11/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 34 YR