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

Catalog Number 12017709122

Device Problem High Test Results (2457)

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

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event occurred in: (b)(6).

Event Description

The customer received questionable thyroid results for 2 patient samples.Of the data provided, the elecsys t4 assay results that are a reportable malfunction apply to only 1 patient sample that was tested on a cobas 6000 e 601 module (serial number not provided) compared to the t4 results from a siemens-immulite 2000xpi, abbott-architect, and a beckman coulter.Please refer to the attachment for patient data.The erroneous results were not reported outside of the laboratory.There was no allegation of an adverse event.This medwatch will cover t4.Refer to medwatch with patient identifier (b)(6) for information on the ft3 iii erroneous results, medwatch with patient identifier(b)(6) for information on the t3 erroneous results, and medwatch with patient identifier (b)(6) for information on the ft4 ii erroneous result.The investigation is currently ongoing.

Manufacturer Narrative

Lot no updated.

Manufacturer Narrative

A patient sample was received for further investigation.The tsh, ft4, ft3, t4, and t3 values generated at the customer site were confirmed.Upon further analysis an interfering factor was detected.This most likely caused the falsely elevated values of the ft4ii, ft3iii, and t4 and an increase value of t3.This interference is covered 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." for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.The incidence rate of the identified interfering factor is monitored on a quarterly basis.

• Brand Name: ELECSYS T4 ASSAY
• Type of Device: RADIOIMMUNOASSAY, TOTAL 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: 7139331
• MDR Text Key: 95824120
• Report Number: 1823260-2017-03102
• Device Sequence Number: 1
• Product Code: CDX
• Combination Product (y/n): N
• Reporter Country Code: HR
• PMA/PMN Number: K961490
• 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
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 12017709122
• Device Lot Number: 194281
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2017
• 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