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

Model Number	TSH
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer¿s e801 module serial number was (b)(6).
Event or Problem Description
The initial reporter complained of discrepant results for 1 patient sample tested for tsh elecsys e2g 300 v2 (tsh) and elecsys ft3 (ft3) on a cobas 8000 e 801 module compared to the abbott method.This medwatch will cover tsh.Refer to medwatch with a1 patient identifier (b)(6) for information on the ft3 results.Refer to the attached data for the patient results.
Additional Manufacturer Narrative
The sample was tested on an e801 module at the investigation site.See attached data for the additional discrepant ft3 and tsh results.The e801 module serial number used at the investigation site was (b)(6).The tsh reagent lot number used at the investigation site was 717918 with an expiration date of 31-oct-2024.The ft3 reagent lot number used at the investigation site was 737314 with an expiration date of 30-nov-2024.The sample was requested for further investigation, however, there was insufficient sample material remaining for additional testing.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS TSH
• 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: 19192688
• Report Number: 1823260-2024-01291
• Device Sequence Number: 15571692
• 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): 05/16/2024

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 Expiration Date: 01/31/2025
• Device Model Number: TSH
• Device Catalogue Number: 08443432214
• Device Lot Number: 74104900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/01/2024
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Female