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

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/25/2019

Event Type  malfunction  

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 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
• Type of Device: ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER
• 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: christopher aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9145242740
• MDR Report Key: 9500555
• MDR Text Key: 220579421
• Report Number: 2432235-2019-00462
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00630414560045
• UDI-Public: 00630414560045
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K102644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: ADVIA 2120I HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER
• Device Catalogue Number: 10285573
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/20/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/07/2015
• 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