MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA SOLUTION WITH DIRECT LOAD

Model Number	ATELLICA SOLUTION WITH DIRECT LOAD
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted siemens to report a delay in testing occurred due to a rack barcode identification misread error on the direct load (dl) module of an atellica solution.Siemens analyzed the available information, including instrument log files and found no evidence of rack barcode read failures.The expected atellica solution behavior when a tube top sampling cup (ttsc) specimen is loaded onto the direct load module with the proper dl rack and with the tube properly seated is that it should process correctly.The actual behavior observed by the operator when the ttsc was properly loaded onto the proper dl rack was a capped tube misreport.As a result, the rack unloaded to the output lane without the specimen being processed.The cause of the rack barcode identification misread error is unknown.The atellica solution is performing within specifications.No further evaluation of this atellica solution is needed.
Event or Problem Description
A delay in testing occurred due to a rack barcode identification misread error on the direct load (dl) module of an atellica solution.The misread error caused one tube top sampling cup (ttsc) specimen to be returned to the output lane without processing the sample.No error messages were posted in the operator log alerting the operator to the issue.There are no known reports of patient intervention or adverse health consequences due to the event.

• Brand Name: ATELLICA SOLUTION WITH DIRECT LOAD
• Common Device Name: ATELLICA SOLUTION WITH DIRECT LOAD
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.; registration #: 8020888; chapel lane; swords, co, dublin, 10040 ; EI 10040
• Manufacturer Contact: karl aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9142550572
• MDR Report Key: 14501240
• Report Number: 2432235-2022-00159
• Device Sequence Number: 5106133
• Product Code: JJE
• UDI-Device Identifier: 00630414002347
• UDI-Public: 00630414002347
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K151767
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/25/2022

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 SOLUTION WITH DIRECT LOAD
• Device Catalogue Number: 11068008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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