MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TSH V2; 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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For 1 event: 1.Summary of investigation results: the investigation is ongoing.2.Summary of follow up/corrective actions taken: the investigation is ongoing.For 2 events: 1.Summary of investigation results: the investigation is ongoing.2.Summary of follow up/corrective actions taken: the patient sample was received for investigation.For all 3 events: 3.Device returned to manufacturer? no.4.Device labeled "for single use?" no.5.Device reprocessed and reused? no.
Event or Problem Description
1.There was an allegation of questionable elecsys tsh v2 results for 3 patients tested on cobas e801 analytical units.2.Patient age range: 58 years, asku 3.Patient weight range: asku 4.Patient sex breakdown: 2-male, 1-asku 5.Patient race breakdown: asku 6.Patient ethnicity breakdown: asku.
Additional Manufacturer Narrative
For two events: 1.Summary of investigation results: the investigation determined that the patient sample contained an interfering factor against the ruthenium component of the tsh assay.Per 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." 2.Summary of follow up/corrective actions taken: the patient sample was investigated.For 1 of the events: 1.Summary of investigation results: the investigation determined that the patient sample contained an interfering factor.Per 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." 2.Summary of follow up/corrective actions taken: the patient sample was investigated.

• 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: 22586692
• Report Number: 1823260-2025-02257
• Device Sequence Number: 19958749
• Product Code: JLW
• UDI-Device Identifier: 07613336157633
• UDI-Public: 07613336157633
• Combination Product (Y/N): N
• PMA/510(K) Number: K190773
• Exemption Number: VMSR
• Number of Events Summarized: 3
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2025

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?: No
• Device Model Number: TSH
• Device Catalogue Number: 08443432190
• Device Lot Number: 858052, ASKU,820386
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 09/17/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown