MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER

Model Number	ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc).A siemens customer service engineer (cse) was dispatched to the customer's site.The cse determined that a screw was missing on the barcode reader.The cse replaced barcode reader mounting bracket and carried out an alignment procedure.The cse verified system function, and quality controls (qc) were run, recovering in range.The cause of the event is unknown.The system is performing according to specifications.No further evaluation of this device is required.Mdr 2432235-2023-00078 was also filed for this event.
Event or Problem Description
Due to a misalignment of the barcode reader on an advia 2120i hematology system with dual aspirate autosampler, incorrect sample identifiers were assigned to patient samples across two days (b)(6) 2023.As a result, 580 samples were repeated on alternate advia 2120/2120i hematology systems, and 280 repeat results were reported, as the correct results, to the physicians.Seven patients were redrawn to obtain correct results.There are no known reports of patient intervention or adverse health consequences due to this event.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2023-00079 on 31-mar-2023.Additional information (03-apr-2023): siemens further evaluated the incident and determined that the missing screw caused the barcode reader to become misaligned.The service actions performed in the initial report corrected the issue.The potential cause of the misaligned barcode reader is the missing screw.The system is performing according to specifications.No further evaluation of this device is required.Investigation findings and investigation conclusions codes in section h6 were updated based on the additional information.Supplemental mdr 2432235-2023-00078_s1 was also filed for this event.

• Brand Name: ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER
• Common Device Name: ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave.; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.; registration number: 8020888; chapel lane, swords, co.; dublin ; EI
• Manufacturer Contact: christopher aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 16657904
• Report Number: 2432235-2023-00079
• Device Sequence Number: 7274693
• Product Code: GKZ
• UDI-Device Identifier: 00630414560045
• UDI-Public: 00630414560045
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K102644
• 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,Followup
• Report Date (Section B): 04/29/2023

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: ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER
• Device Catalogue Number: 10285573
• 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: 03/22/2023
• Supplement Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2015
• 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