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

Catalog Number	07026935190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for two samples from the same patient tested with multiple thyroid assays on a cobas 8000 e 801 module.All complained thyroid results were elevated when measured with the roche assays.The sample results were reported outside of the laboratory.Results from the following assays are affected: ft3, the elecsys ft4 iii assay, anti-tpo, anti-tg, and anti-tshr.The specific ft3, anti-tpo, anti-tg, and anti-tshr reagents used were requested, but not provided.This medwatch will apply to the anti-tpo assay.Refer to the medwatch with patient identifier (b)(6) for information related to the ft3 assay.Refer to the medwatch with patient identifier (b)(6) for information related to the ft4 assay.Refer to the medwatch with patient identifier (b)(6) for information related to the anti-tg assay.Refer to the medwatch with patient identifier (b)(6) for information related to the anti-tshr assay.The first sample was tested on (b)(6) 2022 and had elevated thyroid test results when tested on the e 801 analyzer.When tested at another site using unknown methods, the values were "normal".The second sample was tested on (b)(6) 2022 on the e 801 analyzer.Ft3 and ft4 tests were repeated on an immulite analyzer.This sample was also treated with a heterophilic blocking tube and repeated on the e 801 analyzer.The serial number of the e 801 analyzer was requested, but not provided.Reagent lot and expiration date information was not provided for the sample tested on (b)(6) 2022.Anti-tpo reagent lot 600290 was used for the sample tested on (b)(6) 2022.
Additional Manufacturer Narrative
The customer has confirmed the following reagents were used for ft3, anti-tpo, anti-tg, and anti-tshr: elecsys ft3 iii ver.2, roche diagnostics cobas elecsys anti-tpo, roche diagnostics elecsys anti-tg, elecsys anti-tshr immunoassay ver.2.Medwatch field d4 has been updated.
Additional Manufacturer Narrative
A sample from the patient was provided for investigation.The ft3 and ft4 values obtained by the customer could be reproduced.Further investigations of the sample determined that it contains an interfering factor against the streptavidin component of the ft3, ft4, anti-tpo, anti-tg, and anti-tshr assays.Per 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.".

• Brand Name: ELECSYS ANTI-TPO
• Common Device Name: SYSTEM, TEST, THYROID AUTOANTIBODY
• 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: 14734764
• Report Number: 1823260-2022-01764
• Device Sequence Number: 2426976
• Product Code: JZO
• UDI-Device Identifier: 04015630939626
• UDI-Public: 04015630939626
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K051890
• 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,Followup
• Report Date (Section B): 09/22/2022

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: 08/31/2022
• Device Catalogue Number: 07026935190
• Device Lot Number: 60029001
• 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: 05/24/2022
• Supplement Date Received by Manufacturer: 06/21/2022; 08/31/2022
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 07/13/2022; 09/23/2022
• 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: 64 YR
• Patient Sex: Female