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 2017-11-20 for AQUIOS CL FLOW CYTOMETER B30166 NA manufactured by Beckman Coulter Ireland Inc..
[93182505]
A beckman coulter software engineer arrived at the customer site on 15-nov-2017. The customer's database was retrieved and analyzed for data from the date of event to present. Initial analysis on site showed that there were duplicate sample id events on (b)(6) 2017. Additional analysis performed by software engineers on 16-nov-2017 identified seventeen (17) mis-identified samples and eleven (11) suspicious samples. Further analysis and investigation of the entire database is ongoing. The customer has turned off the auto-release feature and is reviewing each result before releasing it to the laboratory information system (lis). Based on the information available, the assignable cause is an aquios cl software malfunction. The recall (fa-31978) which included notification to the customer and inspection of customers' device data will be updated via additional communication to customers to address this new failure mode. Updated recall to be initiated the week of 27-nov-2017. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[93182506]
The customer reported seeing a recurrence of a previously reported event consisting of patient samples being rerun without being prompted on the aquios cl instrument. The customer alleged that 5 sample ids had been 'reused'. This report (1061932-2017-00020) refers to the event that took place on the date of event. Related report 1061932-2017-00017 refers to the event that took place (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1061932-2017-00020 |
| MDR Report Key | 7046836 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-11-20 |
| Date of Report | 2017-11-06 |
| Date of Event | 2017-11-04 |
| Date Mfgr Received | 2017-11-06 |
| Device Manufacturer Date | 2014-08-01 |
| Date Added to Maude | 2017-11-20 |
| 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 | MRS. LAURIE O'RIORDAN |
| Manufacturer Street | 11800 SW 147TH AVENUE |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal | 33196 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 11800 SW 147TH AVENUE |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33196 |
| 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 | 2017-11-20 |
| Model Number | B30166 |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | HEALTH 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 INC. |
| Manufacturer Address | LISMEEHAN O'CALLAGHAN'S MILLS CO. CLARE EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-20 |