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

Catalog Number	07026919190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
The sample was requested for investigation.
Additional 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
• Common Device Name: 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
• Report Number: 1823260-2022-00667
• Device Sequence Number: 11952343
• Product Code: JZO
• UDI-Device Identifier: 04015630939619
• UDI-Public: 04015630939619
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K053426
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2022

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2022
• Supplement Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 03/12/2022
• Supplement Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 11 YR
• Patient Sex: Female