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

Catalog Number	08496633190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable elecsys ft3 iii, elecsys ft4 iii assay, roche diagnostics cobas elecsys anti-tpo, roche diagnostics elecsys anti-tg, and elecsys anti-tshr results for one patient tested on two cobas 8000 e 801 modules.The serial numbers for the e 801 modules were (b)(4).The patient's elecsys results were reported outside the laboratory.The patient's physician questioned the reported results as the results did not fit the patient's clinical picture.The customer sent the patient's sample to a different laboratory and the sample was tested on an unknown roche analyzer "and had similar results." the patient's sample was sent to another laboratory and tested on a "presumably" siemens analyzer.The customer confirmed the results were within the normal reference ranges, but additional information was requested but not provided.This medwatch is for the anti-tshr assay.Refer to the medwatch with patient identifier (b)(6) for the ft4 assay.Refer to the medwatch with patient identifier (b)(6) for the ft3 assay.Refer to the medwatch with patient identifier (b)(6) for the anti-tpo assay.Refer to the medwatch with patient identifier (b)(6) for the anti-tg assay.
Additional Manufacturer Narrative
The patient's sample was provided for an investigation.The investigation reviewed the system's alarm trace and concluded the customer has acceptable sample quality and no hardware issues.The investigation is ongoing.
Additional Manufacturer Narrative
The customer's calibration and qc results were requested but not provided.The investigation reproduced the customer's elecsys ft4 iii and ft3 iii results.Upon further investigation of the patient sample, an interferent against a component of the reagent was confirmed, streptavidin.This interference is covered in product labeling: "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 ANTI-TSHR
• Common Device Name: 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13671125
• Report Number: 1823260-2022-00582
• Device Sequence Number: 5303314
• Product Code: JZO
• UDI-Device Identifier: 07613336160329
• UDI-Public: 07613336160329
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K193313
• 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): 04/26/2022

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 Catalogue Number: 08496633190
• Device Lot Number: 566091
• 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: 02/09/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 04/26/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INTRALIPID INFUSION THERAPY
• Patient Age: 30 YR
• Patient Sex: Female