MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-10-11 for AQUIOS CL FLOW CYTOMETER B30166 manufactured by Beckman Coulter Ireland.
[90303123]
Beckman coulter specialists conducted an investigation at the customers site and determined that there is a potential for mis-identified samples on the customer's aquios cl flow cytometer resulting in the generation of erroneous results. The customers data base was analyzed by specialists on 2017-9-18. The bec engineers reviewed the database for the impacted aquios cl instrument (serial (b)(4)) and four samples were identified as duplicate. Of the four samples identified as duplicated three of the samples results were flagged by the instrument and alerted the user to a potential problem ((b)(6)). There was only one erroneous result ((b)(6)) that was not flagged. The outcome of having duplicate tests in the system varies according to the number and position of tubes in each cassette, which, in turn, may cause the instrument to resample the same tube or draw the sample from another tube. Each sample id will generate one of the following outcomes: (1) one correct result for the sample, (2) two (or more) correct results for the sample, (3) one incorrect result for the sample - misidentification and (4) one (or more) incorrect results and one (or more) correct results for the sample - misidentification. Based on the initial assessment, the issue occurs because there is a mechanism by which the aquios software will generate a duplicate test when a test query response is received from the laboratory information system (lis) immediately before the query timeout period expires. Once the duplicate test order 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. Beckman coulter initiated a world wide medical device recall on 2017-10-03 (fa-31978). There has been no reoccurrence of this event reported by the customer to date (2017-10-05). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[90303124]
The customer reported that the aquios cl cytometer was running duplicate sample runs after upgrading the software from version 2. 1 to 2. 2. . The customer reported some samples were running two to four times. There has been no report of death, serious injury, or change to patient treatment reported for this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1061932-2017-00015 |
| MDR Report Key | 6942640 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-11 |
| Date of Report | 2017-10-05 |
| Date of Event | 2017-09-11 |
| Date Mfgr Received | 2017-09-11 |
| Device Manufacturer Date | 2014-05-01 |
| Date Added to Maude | 2017-10-11 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 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 CYTOMETER |
| Product Code | OYE |
| Date Received | 2017-10-11 |
| 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 | 2017-10-11 |