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

Model Number	ATELLICA SAMPLE HANDLER PRIME
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) to report that patient hepatitis b surface antigen (hbsag) (hbsii) samples were processed when the assay should have been disabled as quality controls were not processed with the customer set time limit of 24 hours on an atellica sample handler prime.Siemens is investigating the event.
Event or Problem Description
Patient hepatitis b surface antigen (hbsag) (hbsii) samples were tested when quality controls were not processed within the customer set time limit of 24 hours on an atellica sample handler prime.The initial results of negative were reported to the physician(s).The customer stated that the redraw of the patients was not performed at this time.There are no known reports of patient intervention or adverse health consequences due to the event.
Additional Manufacturer Narrative
Siemens filed initial mdr 2432235-2024-00011 with the fda on 19-jan-2024.Additional information (30-aug-2024): based on the information available, the cause of the event is unknown.Instrument files are not available for further investigation.The instrument is performing according to specifications.No further evaluation of this device 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: douglas stanton ; 511 benedict avenue; tarrytown, NY 10591 ; 9142706592
• MDR Report Key: 18547706
• Report Number: 2432235-2024-00011
• Device Sequence Number: 15434648
• Product Code: JJE
• UDI-Device Identifier: 00630414002439
• UDI-Public: 00630414002439
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K161954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2024

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: 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): Follow-Up
• Initial Date Received by Manufacturer: 12/28/2023
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2023
• 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