MAUDE Adverse Event Report: SYSMEX CORPORATION SYSMEX PS-10; PS-10 SAMPLE PREPARATION SYSTEM

Model Number PS-10

Device Problems Mechanical Problem (1384); Failure to Sense (1559); Failure to Deliver (2338)

Patient Problem No Patient Involvement (2645)

Event Date 02/21/2020

Event Type  malfunction  

Manufacturer Narrative

The sample preparation system ps-10 is a fully automated, user-configurable, open system intended for use to prepare human specimens for subsequent analysis on flow cytometers.The system pipettes specimens, reagents, lyse and buffer solutions to prepare samples for flow cytometry analysis.There are no cleared ivd assays for this device.Results obtained from analysis on a flow cytometer may be used in the diagnosis and treatment of certain disease states.Failure to dispense correct volumes of fluorescent-labeled antibody to sample preparations may lead to an erroneous representation of antigen markers present as well as the concentration of the markers in a sample, and generate erroneous results in flow cytometry analysis.Investigation performed on a pre-production device under the conditions described in the event, confirmed a liquid level detection error as a result of incorrect parameter settings in the installation software, with the incorrect parameter settings leading to incorrect calculation of the remaining antibody volume in the vial.Tolerance stack-up of physical/mechanical dimensions on multiple components (vials and reagent blocks), as well as inaccurate z-max teaching were determined to be contributing factors.The investigation determined the variance in the thickness of the glass antibody vials was the cause of the overestimation of remaining antibody in the vials in the event, with the z-max setting a contributing factor.Initial volume of antibody is read from the qr code on the vial or by manual user input into the system.The ps-10 detects the initial antibody volume in the vial and calculates remaining volume as the antibody is pipetted.Greater variation in the thickness of the glass than the ps-10 was designed to accommodate, affects the height of the liquid level detected and can cause an over estimation of the calculated antibody volume.The ps-10 is an open system where any manufacturer's vials may be used.On (b)(6) 2020, sysmex america (sai) was notified that the failure was reproduced on a production ps-10, when testing conditions were simulated to those observed in the failure on the pre-production device.In the u.S.Market, the ps-10 production devices are installed following the ps-10 installation guide.The failure has not been reproduced on a ps-10 device when the device was operated with the settings specified in the ps-10 installation guide.No similar reports of the failure have been received from ps-10 users in the u.S.Sai will notify customers to only use sysmex flat-bottom vials.Adjustment of the ps-10 to ensure accurate pipetting of the sysmex vials must be performed by a sysmex service engineer.This interim solution may result in an increased dead volume of reagent remaining in the antibody vials, but corrects potentially inaccurate under pipetting antibody volume.Verification for other manufacturer's vials to determine settings for accurate level sensing and antibody volume calculation is underway although not yet completed.

Event Description

During beta testing at sysmex europe (seg) on a pre-production sample preparation system ps-10 device, it was observed that the device failed to add the expected amount of fluorescent-labeled antibody reagent to sample preparations for clinical flow cytometry.No warning was issued by the device to alert the operator of insufficient reagent volume and inadequate dispense amount.It was expected that the device would generate a color change on the visual color warning system from blue (adequate reagent volume) to red (insufficient reagent volume) and that processing would stop.The failure was observed on the pre-production device when antibody reagent vials containing 100 microliter (ul) of liquid had been placed onto the device for use, and the device was programmed to multi-pipette six aliquots of 20 ul of reagent (aspirate one 120 ul aliquot and dispense six 20 ul aliquots) into six daughter tubes containing the sample preparations.The actual aspiration volume used for the test scenario totals 143 ul due to additional 15 ul excess aspiration volume and 8 ul conditioning volume.The programmed reagent volume of the multi-pipette sequence used during the failure exceeded the reagent volumes of the vials when placed onto the device for use.The pipetting probes on the device operated with a probe z-max position of 6 steps, 0.6 millimeters (mm) above the absolute z-max (the bottom of the bottle) value.

• Brand Name: SYSMEX PS-10
• Type of Device: PS-10 SAMPLE PREPARATION SYSTEM
• Manufacturer (Section D): SYSMEX CORPORATION; 1-5-1 wakinohama-kaigandori; chuo-ku; kobe, hyogo 651-0 073; JA 651-0073
• Manufacturer (Section G): SYSMEX CORPORATION; 1-5-1 wakinohama-kaigandori; chuo-ku; kobe, hyogo 65100 73; JA 6510073
• Manufacturer Contact: nancy gould ; 577 aptakisic rd; lincolnshire, il ; 5439678
• MDR Report Key: 10175274
• MDR Text Key: 201577862
• Report Number: 1000515253-2020-00017
• Device Sequence Number: 1
• Product Code: PER
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: PS-10
• Device Catalogue Number: BQ716341
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2018
• 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