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

Catalog Number 07027885190

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/08/2021

Event Type  malfunction  

Event Description

The initial reporter complained of discrepant high results for 1 patient sample tested for elecsys t3 (t3), elecsys t4 assay (t4), roche elecsys anti-tg (anti-tg) and roche diagnostics cobas elecsys anti-tpo (anti-tpo) on 2 cobas e801 modules and a cobas 6000 e 601 module compared to an immusystem analyzer and an abbott analyzer.This medwatch will cover t4.Refer to medwatch with patient identifier (b)(6) for information on the t3 results, medwatch with patient identifier (b)(6) for information on the anti-tg results and medwatch with patient identifier (b)(6) for information on the anti-tpo results.Refer to attached data for the patient results.Questionable results were reported outside of the laboratory.The customer¿s e801 module serial number was (b)(4).The serial numbers for the e601 module and the e801 module used at the different laboratories were not provided.The reagent lot numbers used with the e601 module and the e801 module used at the other laboratories were not provided.

Manufacturer Narrative

The sample was requested for investigation.

Manufacturer Narrative

The sample was submitted for investigation.The results generated at the customer site for both the e801 and e601 modules were reproduced during the investigation.Upon investigation of the patient sample, an interferent against the streptavidin component of the reagent was confirmed.This caused the high results for t4, t3, anti-tpo and anti-tg as well as the different results between the e801 module and the e601 modules.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 investigation did not identify a product problem.

• 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: 12917305
• MDR Text Key: 287422907
• Report Number: 1823260-2021-03563
• Device Sequence Number: 1
• Product Code: CDX
• UDI-Device Identifier: 04015630939800
• UDI-Public: 04015630939800
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K961490
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/14/2022

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 Expiration Date: 02/28/2022
• Device Catalogue Number: 07027885190
• Device Lot Number: 495851
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2021
• Initial Date FDA Received: 12/02/2021
• Supplement Dates Manufacturer Received: 01/20/2022
• Supplement Dates FDA Received: 02/14/2022
• 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
• Patient Sequence Number: 1