MAUDE Adverse Event Report: BECKMAN COULTER IRELAND AQUIOS CL FLOW CYTOMETER

Model Number	N/A
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	Test Result (2695)
Date of Event	07/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the software engineering assessment, there is a mechanism by which the aquios software will generate a duplicate test when a test query response is received from the lis immediately before the query timeout period expires - a window in the order of milliseconds in size.Once the duplicate test is created, the software will continue to create duplicate tests as long as there are tubes available (in the cassette and in the stacker).Once all tests have been completed the software reverts to normal operation.The software team stated that the software defect only occurs under these conditions, a test query response times out, and the default test option is on, and when the right tiny time window is hit.All patterns described above are all symptoms of the same root cause problem.When the issue occurs, the system will get stuck producing two requests for each tube.The pattern produced by the duplication depends on the positioning of the tubes in the cassette, which in turn may cause the instrument to resample the same tube or draw the sample from another tube.Based on the information provided by the software team assessment, the failure mode is caused by an aquios cl software malfunction.Recall (fa-31978) included notification to the customer and inspection of customers' device data.(b)(4).Related events: mdr 1061932-2018-00029 (b)(4), 1061932-2018-00030 (b)(4).
Event or Problem Description
On 25-april-2018, beckman coulter (bec) reviewed the information extracted from the database of the customer's aquios cl flow cytometry instrument to determine if any results were impacted by the aquios cl laboratory information system (lis) issue, which could result in duplicate sample requests leading to sample mis-identification.The analysis report, indicates that for instrument serial (b)(4), there were nine sample ids on (b)(6) 2017, there were five sample ids on (b)(6) 2017, and 4 sample ids on (b)(6) 2018 that match the pattern of the known software issue.The sample ids that may have been mis-identified are as follows: sample id: sample (b)(6), (b)(6) 2017.Sample (b)(6), (b)(6) 2017.Sample (b)(6), (b)(6) 2017.Sample (b)(6), (b)(6) 2017.Sample (b)(6), (b)(6) 2017.Sample (b)(6), (b)(6) 2017.Sample (b)(6), (b)(6) 2017.Sample (b)(6), (b)(6) 2017.Sample (b)(6), (b)(6) 2017.Sample (b)(6), (b)(6) 2017.Sample (b)(6), (b)(6) 2017.Sample (b)(6), (b)(6) 2017.Sample (b)(6), (b)(6) 2017.Sample (b)(6), (b)(6) 2017.Sample (b)(6), (b)(6) 2018.Sample (b)(6), (b)(6) 2018.Sample (b)(6), (b)(6) 2018.Sample (b)(6), (b)(6) 2018.

• Brand Name: AQUIOS CL FLOW CYTOMETER
• Common Device Name: FLOW CYTOMETER
• Manufacturer (Section D): BECKMAN COULTER IRELAND; lismeehan; o' callahgan's mills, country clare ; EI
• MDR Report Key: 7531813
• Report Number: 1061932-2018-00028
• Device Sequence Number: 1652125
• Product Code: OYE
• UDI-Device Identifier: 15099590225889
• UDI-Public: (01)15099590225889(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K141932
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Service and Testing Personnel
• Remedial Action: Recall,Notification,Inspection,Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 04/25/2018

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
• Operator of Device: Other Health Care Professional
• Device Model Number: N/A
• Device Catalogue Number: B30166
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2018
• Initial Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2050012-0928/2017-022C
• Patient Sequence Number: 1