MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TSH ASSAY; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Model Number	TSH
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys tsh assay and elecsys ft4 iii assay results for one patient tested on a cobas 8000 e 801 module.The e 801 module serial number was requested but not provided.The patient had a sample collected on (b)(6) 2020 and on (b)(6) 2021.The tsh and ft4 results were reported outside the laboratory.The physician questioned the results and asked for re-measurement of the samples.The customer provided the samples for an investigation and the samples were tested on a cobas 8000 e 801 module, cobas e 411 immunoassay analyzer, and an abbott architect.Refer to the attachment on the medwatch for all the patient data.This mdr is for tsh v1 assay.Refer to the medwatch with patient identifier (b)(6) for tsh v2 assay and (b)(6) for ft4 iii assay.
Additional Manufacturer Narrative
Further investigation of the patient sample was performed.It was determined that there was an interfering factor to f(ab¿)2 fragment of the assay antibody and to the ruthenium label of the tsh assay.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." the investigation is ongoing.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The cause of the event could not be determined.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: ELECSYS TSH ASSAY
• Common Device Name: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12150494
• Report Number: 1823260-2021-01993
• Device Sequence Number: 19761326
• Product Code: JLW
• UDI-Device Identifier: 04015630939831
• UDI-Public: 04015630939831
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K961491
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/06/2021

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: 12/31/2021
• Device Model Number: TSH
• Device Catalogue Number: 07028091190
• Device Lot Number: 495367
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/18/2021
• Supplement Date Received by Manufacturer: 06/18/2021; 08/23/2021
• Initial Report FDA Received Date: 07/12/2021
• Supplement Report FDA Received Date: 08/24/2021; 10/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1