AQUIOS CL FLOW CYTOMETER N/A B30166

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-05-16 for AQUIOS CL FLOW CYTOMETER N/A B30166 manufactured by Beckman Coulter Ireland.

Event Text Entries

[108905070] 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 event: mdr 1061932-2018-00025 (b)(4). Mdr 1061932-2018-00026 (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[108905111] On 13-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 was one incident on (b)(6)2017 (this report), ten incidents on (b)(6) 2017 (1061932-2018-00025), and three incidents on (b)(6) 2018 (1061932-2018-00026) 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1061932-2018-00024
MDR Report Key7519290
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-05-16
Date of Report2018-04-13
Date of Event2017-07-17
Date Mfgr Received2018-04-13
Device Manufacturer Date2015-11-01
Date Added to Maude2018-05-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationSERVICE AND TESTING PERSONNEL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. LAURIE O'RIORDAN
Manufacturer Street11800 SW 147TH AVENUE,
Manufacturer CityMIAMI FL 331962031
Manufacturer CountryUS
Manufacturer Postal331962031
Manufacturer Phone3053802874
Manufacturer G1BECKMAN COULTER, INC.
Manufacturer Street11800 SW 147TH AVENUE
Manufacturer CityMIAMI FL 331962031
Manufacturer CountryUS
Manufacturer Postal Code331962031
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction Number2050012-0928/2017-022C
Event Type3
Type of Report3

Device Details

Brand NameAQUIOS CL FLOW CYTOMETER
Generic NameFLOW CYTOMETER
Product CodeOYE
Date Received2018-05-16
Model NumberN/A
Catalog NumberB30166
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBECKMAN COULTER IRELAND
Manufacturer AddressLISMEEHAN O' CALLAHGAN'S MILLS, COUNTRY CLARE EI


Patients

Patient NumberTreatmentOutcomeDate
10 2018-05-16

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