MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC ATELLICA SAMPLE HANDLER PRIME; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number	11069001
Medical Device Problem Code	Loss of Power (1475)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted siemens to report that the atellica sample handler (sh) lost power and stopped working.A siemens customer service engineer (cse) was dispatched to the customer site to inspect the sh.The cse found a loose connection at the main power circuit breaker.Sparks were observed and there was evidence of damage to a wire insulator.The cse cleaned the contacts and tightened the lug nut on the circuit breaker, restoring the sh to an operational status.The cause of the loss of power to the sh was a loose connection at the main circuit breaker.The analyzer is performing within specifications.No further evaluation of this analyzer is needed.
Event or Problem Description
An outside of the united states (ous) customer contacted siemens to report that the atellica sample handler (sh) lost power and stopped working.Samples were not getting transferred to the analyzer.An alternate atellica solution with an atellica sh was available to continue laboratory operations.There are no reports of harm due to the loss of power at the atellica sh.

• Brand Name: ATELLICA SAMPLE HANDLER PRIME
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; 62 flanders bartley rd; registration #: 2247117; flanders NJ 07836
• Manufacturer Contact: karl aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9142550572
• MDR Report Key: 22309273
• Report Number: 2432235-2025-00166
• Device Sequence Number: 8082251
• Product Code: JJE
• UDI-Device Identifier: 00630414002439
• UDI-Public: (01)00630414002439
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 11069001
• 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: 06/11/2025
• Initial Report FDA Received Date: 06/23/2025
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown