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 01/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

The customer complained of questionable results for 3 separate samples from 1 patient tested for multiple tests on both a cobas 8000 e 602 module or a cobas 8000 e 801 module.Of the data provided, the elecsys tsh assay tsh (tsh), elecsys ft3 iii (ft3 iii), elecsys t4 assay (t4), and elecsys t3 (t3) results from one sample were a reportable malfunction.This one sample was drawn on (b)(6) 2018 and tested on a cobas e602 with the results compared to an abbott system.The customer complained that the patient results do no meet the clinical picture of the patient.The cobas e602 serial number was (b)(4).The rerun results from the sample drawn (b)(6) 2019 are not comparable to the original data since the sample had polyethylene glycol (peg) treatment performed.Samples with peg and without peg treatment are not comparable.The erroneous results were not reported outside of the laboratory.There was no allegation of an adverse event.Medwatchs for this issue include those with (b)(6).The investigation is currently ongoing.

Manufacturer Narrative

The sample from (b)(6) 2018 was submitted for further investigation.The tsh, ft3 iii,t3 and t4 values generated at the customer site for the sample of the were confirmed.An investigation of interference was carried out and the results indicated an interfering factor to a component of the assay.The presence of an interfering factor most likely contributed to the falsely elevated values for the t4, t3, and ft3 iii assays.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." most likely, this same interfering factor was also present in the patient sample from the previous bleeding on (b)(6) 2018, causing discrepant results for the thyroid parameter between the assays of roche diagnostics and abbott.

• 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: 7241291
• MDR Text Key: 99781662
• Report Number: 1823260-2018-00334
• Device Sequence Number: 1
• Product Code: CDX
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2018
• 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: 19428101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2018
• 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: 69 YR