MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2017-08-29 for AQUIOS CL FLOW CYTOMETER B30166 manufactured by Beckman Coulter Ireland.
[83996490]
The data log files from the aquios cl flow cytometer were investigated by the software engineering team and they found three different patterns: one (1) sample id/two (2) different blood tubes. Two (2) different sample ids/same blood tube. Two (2) same sample ids/same blood tube. Ten (10) patient sample results were shown as being run in duplicates which did not lead to patient sample misidentification. Patient sample misidentification occurred for only the last tube in a cassette, and only when there is another cassette in the multiloader of the instrument the assessment completed by beckman coulter software engineering, reported that seven (7) additional instances were identified that lead to erroneous results. 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 by the software team assessment, the failure mode is caused by an aquios cl software malfunction. There have been no reoccurrence of erroneous patient results reported to date (08/24/2017). (b)(4). Related event 1061932-2017-00012 bec identifier (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[83996491]
The customer reported that their aquios cl randomly duplicated patient samples with an alert message "sample id reused". The assessment completed by beckman coulter software engineering, reported that seven (7) additional instances were identified that led to erroneous results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1061932-2017-00013 |
| MDR Report Key | 6827744 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2017-08-29 |
| Date of Report | 2017-08-02 |
| Date of Event | 2017-08-02 |
| Date Mfgr Received | 2017-08-02 |
| Device Manufacturer Date | 2014-05-01 |
| Date Added to Maude | 2017-08-29 |
| 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, INC. |
| Manufacturer Street | 11800 SW 147TH AVENUE |
| Manufacturer City | MIAMI FL 331962031 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 331962031 |
| Single Use | 3 |
| Remedial Action | NO |
| 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 CYTOMETER |
| Product Code | OYE |
| Date Received | 2017-08-29 |
| Model Number | NA |
| Catalog Number | B30166 |
| Lot Number | NA |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER IRELAND |
| Manufacturer Address | LISMEEHAN O' CALLAHGAN'S MILLS, COUNTRY CLARE CA 92821 EI 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-29 |