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 2018-09-27 for AQUIOS CL FLOW CYTOMETER B30166 manufactured by Beckman Coulter Ireland.
[123535708]
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).
Patient Sequence No: 1, Text Type: N, H10
[123535749]
(b)(4) database review identified suspect duplicate sample runs. Field action (b)(4) provides information to customers concerning a software issue which may result in duplicate sample requests leading to sample mis-identification. This can occur when using the aquios cl systems connected to a laboratory information system (lis). All aquios systems susceptible to the lis issue outlined in field action (b)(4) requires data retrieval per service (b)(4) for analysis to determine if any of the available patient result data has been impacted. Analysis of the files from aquios sn: (b)(4) found 2 incidents that matched the pattern of the known software issue. Sample id- (b)(6), (b)(6) 2016. Sample id- (b)(6), (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1061932-2018-01042 |
| MDR Report Key | 7914324 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-09-27 |
| Date of Report | 2018-09-27 |
| Date of Event | 2016-12-09 |
| Date Facility Aware | 2018-05-25 |
| Date Mfgr Received | 2018-05-25 |
| Device Manufacturer Date | 2015-11-01 |
| Date Added to Maude | 2018-09-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LAURIE O'RIORDAN |
| Manufacturer Street | 11800 SW 147TH AVENUE |
| Manufacturer City | MIAMI FL 331962031 |
| Manufacturer Country | US |
| Manufacturer Postal | 331962031 |
| Manufacturer Phone | 3053802874 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 11800 SW 147TH AVENUE |
| Manufacturer City | MIAMI FL 331962031 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 331962031 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2050012-0928/2017-022C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AQUIOS CL FLOW CYTOMETER |
| Generic Name | FLOW CYTOMETRIC REAGENTS AND ACCESSORIES. |
| Product Code | OYE |
| Date Received | 2018-09-27 |
| Model Number | CL |
| Catalog Number | B30166 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER IRELAND |
| Manufacturer Address | LISMEEHAN O?CALLAGHAN?S MILLS COUNTY CLARE EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-27 |