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 Use of Device Problem (1670)

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

Event Date 05/01/2019

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) and reported that the platelet (plt) calibration factor was set to 1.19 on an advia 2120 hematology system with dual aspirate autosampler (serial number: (b)(4)) in may 2019 in order for quality controls (qc) to recover within range.This is a use error as the calibration factor, although within range, should not be changed after being initially set in order to alter qc results.The system was put out of use once the calibration factor had been deemed incorrect and a siemens customer service engineer (cse) was dispatched to the customer site to investigate why qc were not recovering within range.The cse observed that the plt count results on the affected advia 2120 hematology system with dual aspirate autosampler (serial number: (b)(4)) were higher compared with an alternate instrument in the lab.The cse performed a periodic maintenance, replaced a leaking shear face and aligned it, replaced the unified fluidics chamber, replaced the red blood cell flowcell, verified the voltages on the signal processing board (spb) and replaced it.The cse tested the voltages on the existing preamp board which should be the same as the spb; however, the voltage was different when compared to the spb test points.The cse replaced the preamp board and then the voltages matched.The cse was then able to increase the preamp board voltages to -7.5v.The cse ran the original optipoint set gains, which were all within specification.The cse then adjusted the dispense and aspirate positions, after which plt counts decreased.The cause of the qc material to be out of range is unknown.Siemens is investigating the issue.

Event Description

The customer reported to siemens personnel on (b)(6) 2019 that the platelet (plt) calibration factor was set to 1.19 on an advia 2120 hematology system with dual aspirate autosampler (serial number: (b)(4)) in may 2019 in order for quality controls (qc) to recover within range.No patient samples were run once the calibration factor had been deemed incorrect, and the customer discontinued using the system.The customer did not provide patient data but did report that there was no delay in patient testing due to this event.There are no reports of patient intervention or adverse health consequences due to the use of the incorrect platelet calibration factor.

Manufacturer Narrative

Siemens filed the initial mdr 2432235-2019-00253 on 01-aug-2019.Additional information (06-aug-2019): siemens further investigated the issue.The customer reported that there were no discordant patient results obtained as a result of this issue.Additionally, as per the online help advia 120/2120/2120i operator's guide v6.01 section calibration tab: calibration acceptance, an acceptable calibration factor must be between 0.50 and 1.50.In this case a platelet calibration factor was originally 1.19 and gave a higher platelet correlation result.The siemens customer service engineer performed optics bench adjustments and optical alignments, and these actions produced a platelet calibration factor of 1.08.The customer is fully operational.Result code and conclusion code in section h6 were updated based on the additional information.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
• MDR Report Key: 8853119
• MDR Text Key: 194035808
• Report Number: 2432235-2019-00253
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• PMA/PMN Number: K102644
• 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: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• 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
• Date Manufacturer Received: 08/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1