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

Model Number ADVIA 2120 HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 10/28/2019

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) and reported that discordant complete blood count (cbc) parameters were obtained on eleven patient samples on an advia 2120 hematology system with dual aspirate autosampler.A siemens customer service engineer (cse) was dispatched to the site.The cse performed checks for hydraulics, optics, and leaks.The cbc results improved after replacing the sheath rinse.The cse verified acceptable system performance and ran quality controls (qc), which recovered within range.The probable cause of the event was a lack continuous flow of sheath rinse, which pulled air into the system and caused discordant results to be obtained.The system is performing according to specifications.No further evaluation of this device is required.

Event Description

Discordant complete blood count (cbc) parameters were obtained on eleven patient samples on an advia 2120 hematology system with dual aspirate autosampler.The discordant parameters include white blood cells (wbc), red blood cells (rbc), hemoglobin (hgb), hematocrit (hct), mean corpuscular volume (mcv), mean corpuscular hemoglobin (mch), mean corpuscular hemoglobin concentration (mchc), corpuscular hemoglobin concentration mean (chcm), red cell distribution width (rdw), hemoglobin distribution width (hdw), platelets (plt), mean platelet volume (mpv), neutrophils (neut), lymphocytes (lymph), monocytes (mono), basophils (baso), large unstained cells (luc), and nucleated red blood cells (nrbc).The discordant results were reported to the physician(s) and were questioned by the physician(s).The original samples were repeated on an alternate advia 2120 hematology system and were also repeated on the original system.The repeat results obtained were considered correct and matched the patients' clinical histories.There are no reports of patient intervention or adverse health consequences due to the discordant complete blood count (cbc) parameters.

• Brand Name: ADVIA 2120 HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER
• Type of Device: ADVIA 2120 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: 9383448
• MDR Text Key: 208118895
• Report Number: 2432235-2019-00435
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/27/2019

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 2120 HEMATOLOGY SYSTEM WITH DUAL ASPIRATE AUTOSAMPLER
• Device Catalogue Number: 10313419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2019
• Initial Date FDA Received: 11/27/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/15/2007
• 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