MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA SAMPLE HANDLER PRIME

Model Number	ATELLICA SAMPLE HANDLER PRIME
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted a siemens customer care center to report an atellica sample handler prime was directly affected by fire.This led to the loss of functionality on the atellica sample handler prime.The customer has completed an investigation of the event and has generated a report of the findings.Siemens has requested a copy of the report but has not received a copy of the report and have no awareness of its contents.Additionally, siemens has requested the opportunity to examine the instrument but has not been permitted onsite to investigate.Siemens will continue to await the receipt of the investigation report and response to requests for access to the instrument for investigation.
Event or Problem Description
An outside the united states customer reported an atellica sample handler prime was directly affected by fire.There were no injuries reported.There was no delay in patient testing reported as this facility is a forensic laboratory.There are no known reports of adverse health consequences due to the event.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2025-00310 on 08-dec-2025.Additional information (01-apr-2026): siemens further evaluated the event and concluded that the atellica sample handler prime (shp) was connected to atellica ch 930 analyzer that was exposed to fire.The shp was damaged by heat.The fire did not start in this instrument.The investigation findings and investigation conclusion codes in section h6 were updated to reflect the additional information.No further investigation into this instrument is required.

• Brand Name: ATELLICA SAMPLE HANDLER PRIME
• Common Device Name: ATELLICA SAMPLE HANDLER PRIME
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; registration #: 2247117; flanders NJ 07836
• Manufacturer Contact: kristin kehyaian ; 511 benedict ave.; tarrytown, NY 10591 ; 9148267101
• MDR Report Key: 23744920
• Report Number: 2432235-2025-00310
• Device Sequence Number: 18260100
• Product Code: JJE
• UDI-Device Identifier: 00630414002439
• UDI-Public: (01)00630414002439
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K161954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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: Other
• Device Model Number: ATELLICA SAMPLE HANDLER PRIME
• Device Catalogue Number: 11069001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2021
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown