MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TSH V2; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Model Number	TSH
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results for other tests performed on the sample had flags indicating there was a sample bubble.Controls were within range after the event.A review of alarm trace data showed sample clot detection alarms on the day of the event.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with elecsys tsh v2, elecsys cortisol ii, and elecsys ft4 iv on a cobas e 801 analytical unit.This medwatch will apply to the tsh assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the cortisol assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the ft4 assay.The sample initially resulted in the following values: tsh = 0.0171 miu/l cortisol = < 1.50 nmol/l with a data flag ft4 = < 0.500 pmol/l with a data flag.The sample repeated with the following values on (b)(6) 2026: tsh = 3.23 miu/l cortisol = 527 nmol/l ft4 = 16.3 pmol/l.
Additional Manufacturer Narrative
A review of sample images from the analyzer showed bubbles on the sample.The investigation determined the issue is consistent with insufficient pre-analytic sample handling.

• Brand Name: ELECSYS TSH V2
• Common Device Name: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 24689364
• Report Number: 1823260-2026-01074
• Device Sequence Number: 21342558
• Product Code: JLW
• UDI-Device Identifier: 07613336157633
• UDI-Public: 07613336157633
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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): 04/17/2026

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 Model Number: TSH
• Device Catalogue Number: 08443432190
• Device Lot Number: 911795
• 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: 02/24/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 04/17/2026
• 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: Unknown