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	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).A siemens customer service engineer (cse) was dispatched to the customer site.Quality controls (qc) recovered within range at the time of the event.Sample aspiration showed multiple flags including a hemoglobin (hgb) delta check flag, a nucleated red blood cell (nrbc) flag, and comparison error flags.As per the advia 2120/2120i operators guide, section 6, page 21, sample/system flags: "through the use of complex flagging algorithms, laboratory personnel are alerted to suspected abnormal sample and/or system conditions.Sample/system flags appear on the run screen and the review / edit tab.Whenever such flags are triggered, the user should review the results and take the action recommended." in this case the results were released without review.Therefore, this event can be attributed to use error.The system is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
Discordant, falsely elevated hemoglobin (hgb), hematocrit (hct), and red blood cell (rbc) results were obtained on a patient sample on an advia 2120i hematology system with dual aspirate autosampler (serial number: (b)(4)).The discordant results were reported to the physician(s) and were questioned.The same sample was rerun for hgb, hct, and rbc on the customer's alternate advia 2120i hematology system, resulting lower.The repeat results were reported, as the correct results, to the physician(s).Discordant, falsely elevated hgb and hct results were also obtained on a second patient sample using the advia 2120i hematology system with dual aspirate autosampler (serial number: (b)(4)).The discordant results were reported to the physician(s) and were questioned.The same sample was repeated for hgb and hct on the same system, resulting lower.The same sample was then rerun for hgb and hct on the customer's alternate advia 2120i hematology system, also resulting lower and confirming the repeat results.The repeat 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 elevated hemoglobin (hgb), hematocrit (hct), and red blood cell (rbc) 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
• MDR Report Key: 9990459
• Report Number: 2432235-2020-00276
• Device Sequence Number: 11883032
• Product Code: GKZ
• UDI-Device Identifier: 00630414560045
• UDI-Public: 00630414560045
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K102644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2020

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: No Information
• 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: 03/27/2020
• Initial Report FDA Received Date: 04/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1