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

Model Number	TSH
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
1.Describe the event: the initial reporter complained of a discrepant low result for 1 patient tested for elecsys tsh on a cobas 8000 e 801 module and 1 patient tested on a cobas 8000 e 602 module.2.Patient age range: asku.3.Patient weight range: asku.4.Patient sex breakdown: asku.5.Patient race breakdown: asku.6.Patient ethnicity breakdown: asku.
Additional Manufacturer Narrative
For one of the events: 1.Summary of investigation results: the investigation could not identify a product problem.The cause of the event could not be determined.2.Summary of follow up/corrective actions taken: the issue was resolved after the replacement of the reagent pack.For one of the events: 1.Summary of investigation results: the investigation determined the event was consistent with sample pipetting issues, however, based on the limited information provided, the specific cause of the event could not be determined.2.Summary of follow up/corrective actions taken: calibration was acceptable.The customer did not provide any additional information.3.Device returned to manufacturer? no.4.Device labeled "for single use?" no.5.Device reprocessed and reused? no.
Additional Manufacturer Narrative
Medwatch exemption number field was updated to vmsr.

• 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: 20501221
• Report Number: 1823260-2024-03039
• Device Sequence Number: 18022334
• Product Code: JLW
• UDI-Device Identifier: 07613336193693
• UDI-Public: 07613336193693
• Combination Product (Y/N): Y
• PMA/510(K) Number: K190773
• Exemption Number: VMSR
• Number of Events Summarized: 2
• 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): 03/05/2025

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: 08443432214
• Device Lot Number: 77243400,76490401
• 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: 03/05/2025
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 03/05/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown