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 Low Test Results (2458)

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

Event Date 08/02/2022

Event Type  malfunction  

Event Description

Multiple discordant complete blood count (cbc) results were obtained on a patient sample on an advia 2120 hematology system with dual aspirate autosampler.The discordant results were reported to the physician(s).Due to the low hemoglobin (hgb), red blood cells (rbc), and white blood cells (wbc), the patient underwent an esophagus gastroscopy, which was negative.The patient was not injured due to the esophagus gastroscopy.Three days later, the same sample was rerun for a cbc, and the results were different compared to the initial aspiration.The rerun results were reported, as the correct results, to the physician(s).There are no known reports of adverse health consequences due to the esophagus gastroscopy.Statements and actions attributed to the customer are derived from information submitted to the siemens complaint handling system and have not been verified.

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range at the time of the event.A siemens customer service engineer (cse) was sent to the customer site to verify system performance.While there was no report of injury to the patient due to the esophagus gastroscopy, the incident is being reported because the procedure may have been unnecessary.Pathological cbc count, should trigger repeat testing, followed by manual cell counts and if confirmed, further laboratory and / or imaging investigations.Cbc count delivers a first line screening result, which needs to be confirmed by manual count / peripheral smear if results are found to be pathological.Preanalytical variable, such as an over filled, or an underfilled tube, time of sample collection, storage and transport conditions could affect results.Mitigations would include running the tests on an alternate analyser and correlation with peripheral smear.The results would also be correlated with patients clinical signs and symptoms.Esophagus gastroscopy is a safe, risk-poor and relative painless procedure.A sole anemia pattern should not alone trigger such procedure.Siemens is investigating the issue.

Manufacturer Narrative

Siemens filed the initial mdr on 23-sep-2022.Additional information (01-nov-2022): the sample aspiration showed abnormal low results for white blood cells (wbc), red blood cells (rbc), hemoglobin (hgb) and hematocrit (hct).The laboratory sets these ranges in the software so that when a result is outside the expected range established by the laboratory, the user should review the results and take action.No action was taken in this case and the results were released.Quality controls (qc) recovered in range at the time of the event.Pre-analytical factors cannot be ruled out as a potential cause of the event.The cause of the event is unknown.The system is performing according to specifications.No further evaluation of this device is required.

• 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 ; 9144153450
• MDR Report Key: 15476955
• MDR Text Key: 306356583
• Report Number: 2432235-2022-00268
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K102644
• 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,Followup
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2022
• 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
• Date Manufacturer Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/14/2007
• 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
• Patient Age: 55 YR
• Patient Sex: Female