MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TSH ELECSYS E2G 300 V2; THYROID-STIMULATING HORMONE ASSAY

Catalog Number	08443432214
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's e801 analyzer was requested but not provided.The serial number of e801 analyzer used for investigation is (b)(6).The serial number of e411 analyzer used for investigation is (b)(6).The ft3 iii v2 reagent lot number and expiration date used at the customer's site were not provided.The ft3 iii v2 reagent lot number used on cobas e801 was 669112 with an expiration date of 29-feb-2024.The ft3 iii v2 reagent lot number used on cobas e411 was 686656 with an expiration date of 30-apr-2024.The tsh v2 reagent expiration date used at the customer's site was not provided.The tsh v2 reagent lot number used on cobas e801 was 714216 with an expiration date of 31-aug-2024.The tsh v2 reagent lot number used on cobas e411 was 706442 with an expiration date of 29-feb-2024.Assays from different manufacturers can generate different results.This relates to the overall setups of the assays, the antibodies used, differences in reference materials, and the standardization methodology used.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for 4 patients' samples tested with elecsys ft3 g3 v2 (ft3 iii v2) assay, and tsh v2 (tsh v2) assay on a cobas 8000 e801 module.The samples also had discrepant results when tested on another cobas 8000 e801 module and on a cobas e411 immunoassay analyzer.This medwatch will apply to the tsh v2 assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the ft3 iii v2 assay.Refer to the attachment for all patients' data.The samples were initially tested on the customer's e801 analyzer.The samples were provided for investigation where they tested on a 2nd e801 analyzer and on e411 analyzer.The samples were also repeated on an abbott architect analyzer.
Additional Manufacturer Narrative
Two samples were received for investigation on 18-jan-2024.Upon investigation of the samples, no interference was detected.The investigation did not identify a product problem.Product labeling for tsh and ft3 iii state: for diagnostic purposes, the results should always be assessed in conjunction with the patient´s medical history, clinical examination, and other findings.

• Brand Name: TSH ELECSYS E2G 300 V2
• Common Device Name: THYROID-STIMULATING HORMONE ASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18230631
• Report Number: 1823260-2023-03789
• Device Sequence Number: 6203111
• Product Code: JLW
• UDI-Device Identifier: 07613336193693
• UDI-Public: 07613336193693
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K190773
• 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): 04/11/2024

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: 08443432214
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2023
• Supplement Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 04/11/2024
• 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 Sex: Unknown