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)
Date of Event	11/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Roche diagnostics received an allegation of questionable high results for two samples collected from the same patient and tested with elecsys tsh v2 on a cobas 8000 e 801 modules.The patient was allegedly treated with levothyroxine after measurements were performed with the first sample and the dosage was allegedly increased after measurements were performed with the second sample.The first sample reportedly resulted in a tsh value of 3.74 mu/l when tested with the roche method on the first e 801 analyzer.The same sample was tested using the siemens method and the tsh result was reported to be 0.01 mu/l.The sample was tested with the roche method after polyethylene glycol (peg) precipitation and the tsh recovery was reportedly 1 %.The sample was also tested with the roche method after treatment in a heterophilic antibody blocking tube and it was reported that there was no indication of heterophilic antibodies.After the first sample measurement, the patient was assumed to have hypothyroidism and was reportedly treated with levothyroxine.It was asked, but it is not known if the patient was treated with levothyroxine based on the tsh value obtained with the roche method.On (b)(6) 2026, the second sample collected from the patient was tested with the roche method on a second e801 analyzer, reportedly resulting in a tsh value of 5.99 mu/l.The sample was repeated using the siemens method and the tsh result was reportedly 1.68 mu/l.The sample was tested with the roche method after peg precipitation and the tsh recovery was reportedly 17 %.The patient's levothyroxine dosage was reportedly increased because the physician expected a suppression of tsh, but this did not occur.The increased dosage was reportedly done as a result of the high tsh value measured with the roche method.The results obtained with the siemens method were reported to fit clinical expectations and this reportedly led to a reduction and tapering off of the patient's levothyroxine medication.There was no allegation of harm or injury to the patient.
Additional Manufacturer Narrative
The serial number of the first e 801 analyzer is (b)(6).The serial number of the second e 801 analyzer is (b)(6).The patient's samples were provided for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
Investigations of the provided patient material determined that the sample contains an interfering factor against the ruthenium component of the tsh assay, leading to a falsely elevated result.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.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." the investigation did not identify a product problem.

• 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: 24201278
• Report Number: 1823260-2026-00307
• Device Sequence Number: 9855394
• Product Code: JLW
• UDI-Device Identifier: 07613336157633
• UDI-Public: 07613336157633
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 04/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TSH
• Device Catalogue Number: 08443432190
• Device Lot Number: 90637101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 04/10/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White