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	06/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys tsh 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's initial elecsys tsh result was reported outside the laboratory.The physician questioned the elecsys tsh result and requested re-measurement of the patient's sample.The customer performed repeat testing on an abbott architect analyzer.The customer sent the sample for investigation and the patient's sample was tested on an e 801 module and a cobas e 411 immunoassay analyzer.The customer's e 801 module serial number was requested but not provided.This medwatch is for tsh assay version refer to the medwatch with patient identifier (b)(6) for the tsh assay version 2.
Additional Manufacturer Narrative
The sample was submitted for investigation and tested with tsh v2 reagent lot 551796 on a cobas e801 module.The result was 4.79 uiu/ml which is slightly higher than the reference range.Further investigation of the sample confirmed an interfering factor in the sample that interferes both with the ru-label component and the fab'2 component of the detecting antibody of the assay.These interferences are addressed 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 TSH ASSAY
• Common Device Name: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12136277
• Report Number: 1823260-2021-01968
• Device Sequence Number: 17313189
• 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
• Report Date (Section B): 09/09/2021

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
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1