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

Model Number ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER

Device Problem Mechanical Problem (1384)

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

Event Date 01/10/2018

Event Type  malfunction  

Manufacturer Narrative

A siemens healthcare diagnostics (siemens) field service engineer (fse) was dispatched to the operator's site to determine the cause of the discordant results on multiple parameters of the complete blood count (cbc) on the advia 2120i hematology system with single aspirate autosampler.The fse inspected the system and found no issues with the needle and the needle housing.The fse also checked and adjusted the alignment of the shear face alignment and the selector valve alignment.Then, the fse ran fresh blood in three modes and determined that there was air in lines when the sample was run in the autosampler mode.Then, the fse tightened the needle, which resolved the air in lines when running samples.The fse also ran two precision runs of fresh blood in autosampler mode and ran quality controls, which recovered within tolerance.The system is performing according to specifications.No further evaluation of this system is required.

Event Description

Discordant, falsely low white blood cell (wbc), red blood cell (rbc), hemoglobin (hgb), and hematocrit (hct) results were obtained on a patient sample on the advia 2120i hematology system with single aspirate autosampler.Other parameters in the initial complete blood count (cbc) were also impacted by this event.These results were reported to the physician(s), who questioned the results as the physician(s) expected an elevated hgb result.The same sample was manually rerun on the same system, resulting higher than the initial results.The patient's blood was redrawn and run on the same system, resulting higher than the initial results.The results obtained on the redrawn sample were expected and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant results on multiple parameters of the cbc.

Manufacturer Narrative

Siemens filed the initial mdr 2432235-2018-00036 on 29-jan-2018.Additional information (19-feb-2018): a siemens headquarters support center (hsc) specialist further investigated the cause of the discordant, falsely low results for multiple parameters of the complete blood count (cbc) on the advia 2120i hematology system with single aspirate autosampler.The affected results were obtained on a sample that was processed using the autosampler.The autosampler was affixed with an autosampler aspiration needle.The hsc specialist determined that the air, mixed with the patient sample, caused the discordant, falsely low results.The field service engineer (fse) that was dispatched onto the customer's site tightened the needle to the autosampler base.By doing so, the fse stopped the flow of air into the sample line.Corrected information (16-mar-2018): section b6 of the initial mdr indicates that pct was the abbreviation for procalcitonin.Pct is not the abbreviation for procalcitonin; it is the abbreviation for plateletcrit.Additionally, li is the abbreviation for lobularity index.Section b6 was updated to correct this information.

• Brand Name: ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER
• Type of Device: ADVIA 2120I HEMATOLOGY SYSTEM WITH SINGLE ASPIRATE AUTOSAMPLER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 7226963
• MDR Text Key: 98756465
• Report Number: 2432235-2018-00036
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00630414581965
• UDI-Public: 00630414581965
• Combination Product (y/n): N
• PMA/PMN Number: K162977
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2018
• 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 SINGLE ASPIRATE AUTOSAMPLER
• Device Catalogue Number: 10488923
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 86 YR