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 Known Impact Or Consequence To Patient (2692)
Date of Event	11/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc) and reported that discordant, falsely low complete blood count (cbc) parameters were obtained on two patient samples on an advia 2120i hematology system with dual aspirate autosampler.A siemens customer service engineer (cse) was dispatched to the customer site.The cse found the reagent leaking from the reagent tubing which was twisted and split.The tubing was replaced, the reagent block was cleaned, the analyzer was cleaned and the reagents in the system were primed.In a follow-up visit, the cse ran priming for the reagents and ran several precision runs.No outliers were observed during the runs after the reagent lines and pump were replaced.Quality controls (qc) were run and recovered within specifications.The cause of the discordant results was a combination of the damaged reagent tubing and the dirty reagent block.The system is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
Discordant, falsely low complete blood count (cbc) parameters were obtained on two patient samples on an advia 2120i hematology system with dual aspirate autosampler.The discordant parameters include white blood cells (wbc), red blood cells (rbc), hemoglobin (hgb), hematocrit (hct), and platelets (plt).The discordant results were not reported to the physician(s).The two patient samples were repeated for wbc, rbc, hgb, hct, and plt on an alternate advia 2120i hematology system, resulting higher.These results were reported, as the correct results, to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low white blood cells (wbc), red blood cells (rbc), hemoglobin (hgb), hematocrit (hct), and platelets (plt) results.

• 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: 9500555
• Report Number: 2432235-2019-00462
• Device Sequence Number: 1878437
• 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
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2019

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: 11/26/2019
• Initial Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1