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	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).An onsite siemens customer service engineer (cse) serviced the advia 2120i hematology system with dual aspirate autosampler and noted that the red blood cell (rbc) rate was inconsistent.Platelets are counted in the rbc channel, and therefore if the rate is inconsistent for rbc, it will be inconsistent for platelets as well since they are counted at the same time.The cse backflushed the flowcell which improved the rbc rate.The cse also inspected the rbc optics and adjusted the pulse width to be within specification.Quality controls (qc) recovered in range after the service intervention and the system was operational.The cause of the falsely low platelet result was the dirty flowcell and/or the rbc optics.The system is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A discordant, falsely low platelet result was obtained on a patient sample on an advia 2120i hematology system with dual aspirate autosampler.The discordant result was reported to the physician(s) and was questioned.The sample was repeated for platelet on an alternate advia 2120i hematology system, resulting higher.The higher result was reported, as the correct result, to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low platelet result.

• 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
• MDR Report Key: 10838428
• Report Number: 2432235-2020-00449
• Device Sequence Number: 3274803
• 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,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/13/2020

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2020
• Initial Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1