MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-02-13 for AQUIOS CL FLOW CYTOMETER B30166 manufactured by Beckman Coulter Ireland.
[99958429]
During a software assessment at beckman coulter, it was found when the stat door of the aquios cl was opened and a sample was placed in the door, the sample information was entered and the sample door was closed and immediately opened. A new sample was placed in the door, the new sample information was entered, and the door was closed again. The instrument processed the new sample twice using both the correct sample id and information and the sample id and information of the first tube which was presented and immediately removed. Although the issue was discovered during internal verification testing, the event represents a potential for erroneous results due to sample mis-identification if it were to occur at a customer site. There have been no reports of this issue from customer sites to date (17-jan-2018). Internal bec identifier (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[99958430]
The submitter reported that the aquios cl processed the same sample with two different sample ids and sample information at the stat door (single tube door). There were no error messages/flags reported by the customer at the time of the event. Erroneous patient results were not generated. The problem was discovered internally at beckman coulter during verification testing for a new software version release. This event can occured in the currently released versions of the software (2. 0, 2. 0. 1, 2. 1).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1061932-2018-00001 |
| MDR Report Key | 7268017 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-02-13 |
| Date of Report | 2018-01-23 |
| Date of Event | 2018-01-02 |
| Date Mfgr Received | 2018-05-01 |
| Device Manufacturer Date | 2013-11-01 |
| Date Added to Maude | 2018-02-13 |
| 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 | SERVICE AND TESTING PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LAURIE O'RIORDAN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 3053802874 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 250 S KRAEMER BLVD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AQUIOS CL FLOW CYTOMETER |
| Generic Name | FLOW CYTOMETER |
| Product Code | OYE |
| Date Received | 2018-02-13 |
| Model Number | CL |
| Catalog Number | B30166 |
| Operator | SERVICE AND TESTING PERSONNEL |
| 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 92821 EI 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-13 |