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

Model Number N/A

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/31/2023

Event Type  malfunction  

Event Description

A falsely elevated platelet (plt) result was obtained on a patient sample on an advia 2120i hematology system (serial number (b)(6).The erroneous result was not reported to the physician(s).A different sample from the same patient was repeated on the same advia 2120i hematology system.Additionally, the original sample was repeated on an alternate advia 2120i hematology system (serial number (b)(6) and an alternate method.The repeat results were lower than the erroneous result.The repeat result was reported, as the correct result, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated platelet (plt) result.

Manufacturer Narrative

An outside united states (ous) customer contacted a siemens customer care center to report a falsely elevated platelet (plt) result that was obtained on a patient sample on an advia 2120i hematology system.Upon review of the results sent by the country and attached to the complaint, the sample aspiration shows multiple flags and warnings, the plt result in this case is flagged.The advia 2120/2120i operators guide, smn 10708774, section 6, page 21, sample/system flags, states "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." the complaint also states the rbcifr flag was present to alert the operator to a system issue that needed to be addressed.This should be considered normal troubleshooting.The advia 2120i hematology system is performing as intended.A product performance issue has not been identified.No further evaluation of the device is required.

• Brand Name: ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE
• Type of Device: ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.; registration number: 8020888; chapel lane, swords, co.; dublin ; EI
• Manufacturer Contact: karen confort ; 333 coney street; walpole, MA 02032 ; 3392069063
• MDR Report Key: 18345811
• MDR Text Key: 330819121
• Report Number: 2432235-2023-00325
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00630414019772
• UDI-Public: 00630414019772
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: K162977
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11219529
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2023
• Date Device Manufactured: 04/12/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 5 YR
• Patient Sex: Male