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

Model Number	ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens became aware of discordant red blood cell (rbc) count and platelet (plt) results that were obtained on patient samples on an advia 2120i hematology system with dual aspirate autosampler.The customer performed a system decontamination, which resolved the issue.The customer indicated that the system is performing according to specifications.Siemens is investigating the issue.
Event or Problem Description
Discordant red blood cell (rbc) count and platelet (plt) results were obtained on a patient sample(s) using an advia 2120i hematology system with dual aspirate autosampler.The discordant results were not reported to the physician(s).The customer performed repeat testing using a non-siemens instrument.The repeat results were reported, as the correct results, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant rbc and plt results.
Additional Manufacturer Narrative
Siemens filed the initial mdr on 28-mar-2019.Additional information (09-apr-2019): siemens further investigated the issue and determined that the definitive root cause of the issue could not be identified.However, the event data indicates that the service actions performed by the hospital engineer, including clearing the red blood cell (rbc)/platelet (plt) chamber (system decontamination), resolved the reported issue.The result code and conclusion code were updated based on the additional information.The system is performing according to specifications.No further evaluation of this device is required.

• 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: 8460914
• Report Number: 2432235-2019-00114
• Device Sequence Number: 3013396
• Product Code: GKZ
• UDI-Device Identifier: 00630414560045
• UDI-Public: 00630414560045
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 04/26/2019

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 WITH DUAL ASPIRATE AUTOSAMPLER
• Device Catalogue Number: 10285573
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 04/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1