MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-TSHR; THYROID AUTOANTIBODY TEST

Catalog Number 08496633190

Device Problem High Test Results (2457)

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

Event Date 08/16/2022

Event Type  malfunction  

Event Description

The initial reporter complained of high results for 1 patient sample tested for elecsys anti-tshr (anti-tshr) on a cobas e801 module.The sample was submitted for investigation where discrepant results were identified between the customer's e801 module, an e801 module used at the investigation site, and an outsourced yamasa analyzer.The result from the customer¿s e801 module was 5.6 iu/l.The result from the e801 module used at the investigation site was 5.88 iu/l.The result from the yamasa analyzer was < 1.0 iu/ml.The customer¿s e801 module serial number was not provided.The e801 module serial number used at the investigation site was 14d9-06.

Manufacturer Narrative

The sample was requested for investigation.

Manufacturer Narrative

The sample was investigated further where the high anti-tshr results were reproduced.The investigation determined the patient's sample contained an interfering factor against the ruthenium label component of the reagent which caused the high results.Product labeling states: "in rare cases, interference due to extremely high titers of antibodies to test 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 ANTI-TSHR
• Type of Device: THYROID AUTOANTIBODY TEST
• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15497228
• MDR Text Key: 301276711
• Report Number: 1823260-2022-02961
• Device Sequence Number: 1
• Product Code: JZO
• UDI-Device Identifier: 07613336160329
• UDI-Public: 07613336160329
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K193313
• 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: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 08496633190
• Device Lot Number: 566091
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2022
• 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