MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC ADVIA 2120I WITH DUAL ASPIRATE; COUNTER, DIFFERENTIAL CELL

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside the united states customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding a falsely elevated platelet result was obtained on an advia® 2120i hematology system.Quality control (qc) recovered within range.Per the advia® 2120i hematology system.Operators guide, whenever morphology or quantitative flags are triggered, before reporting patient results, the laboratory, must validate the results and take appropriate action in accordance with established standard operating procedures.Alignment of rbc optical channel, which is considered part of normal troubleshooting, was performed to resolve the issue.The system is operational once again and performing as expected.No further investigation is required.
Event or Problem Description
The customer reported an erroneously falsely elevated platelet result was obtained on an advia® 2120i hematology system, serial number: (b)(6).The falsely elevated patient result was not reported to the physician.The sample was reprocessed on the same system and recovered similar to the initial result.The sample was reprocessed a second time on an alternate advia® 2120i hematology system and recovered lower.The sample was processed a third time on a non-siemens instrument and recovered lower.The lower result from the alternate advia® 2120i hematology system was correct, reported, and was similar to a historical result.There is no known reports of patient intervention or adverse health consequences due to the issue.

• Brand Name: ADVIA 2120I WITH DUAL ASPIRATE
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LIMITED; chapel lane; registration number: 8020888; swords co. dublin ; EI
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 19999315
• Report Number: 2432235-2024-00185
• Device Sequence Number: 7164477
• Product Code: GKZ
• UDI-Device Identifier: 00630414560045
• UDI-Public: (01)00630414560045
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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
• Report Date (Section B): 08/16/2024

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: N/A
• Device Catalogue Number: 10285573
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 08/18/2024
• Date Device Manufactured: 04/01/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male