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

Catalog Number 07026919190

Device Problem High Test Results (2457)

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

Event Date 02/03/2022

Event Type  malfunction  

Event Description

The initial reporter received questionable elecsys anti-tpo results for 2 patients and questionable elecsys anti-tg results for 1 patient tested with a cobas e 801 analytical unit serial number (b)(4) compared to a cobas e 602 serial number (b)(4).(b)(6).This result was released to medical personnel.This medwatch is for the anti-tg assay.Refer to medwatch with patient identifier (b)(6) for the anti-tpo assay.

Manufacturer Narrative

The sample was requested for investigation.

Manufacturer Narrative

Section d4, expiration date was updated.Both patient samples were received for investigation.The customer's roche results were reproduced.Further investigation confirmed an interfering factor against the streptavidin component of the reagent for both patient samples causing the high results for anti-tpo and anti-tg.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: ROCHE ELECSYS ANTI-TG
• Type of Device: THYROID AUTOANTIBODY TEST SYSTEM
• 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: 13742238
• MDR Text Key: 293083709
• Report Number: 1823260-2022-00667
• Device Sequence Number: 1
• Product Code: JZO
• UDI-Device Identifier: 04015630939619
• UDI-Public: 04015630939619
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K053426
• 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: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 07026919190
• Device Lot Number: 57427600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2022
• 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
• Patient Age: 11 YR
• Patient Sex: Female