MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2017-10-20 for AQUIOS CL FLOW CYTOMETER B30166 manufactured by Beckman Coulter Ireland.
[90684171]
The data log files from the aquios cl flow cytometer were investigated by the software engineering team and they found three different patterns: o one (1) sample id/two (2) different blood tubes o two (2) different sample ids/same blood tube o two (2) same sample ids/same blood tube data analysis for the instrument (serial (b)(4)) was been completed for a total of 18,613 samples ranging from august 19, 2015 through august 1, 2017. The assessment completed by beckman coulter software engineering reported that a total of six (6) instances were identified that led to erroneous results. To date the analysis has confirmed that only the sample ids listed below were affected. ? 170002213091,? 170002214091,? 170002225091,? 170002227091,? 170002233091,? 170002232091. Based on the information by the software team assessment, the failure mode is caused by an aquios cl software malfunction. (b)(4). Related events: 1061932-2017-00012 (b)(4). 1061932-2017-00013 (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[90684172]
While doing a database analysis for a customer, the beckman coulter software engineering team identified that the customer's second instrument ((b)(4)) had a total of six (6) instances identified that led to erroneous results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1061932-2017-00016 |
| MDR Report Key | 6964836 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2017-10-20 |
| Date of Report | 2017-10-19 |
| Date of Event | 2017-08-02 |
| Date Mfgr Received | 2017-09-20 |
| Device Manufacturer Date | 2014-11-01 |
| Date Added to Maude | 2017-10-20 |
| 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 | 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 | Z2050012-0928/2017-022C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AQUIOS CL FLOW CYTOMETER |
| Generic Name | FLOW CYTOMETER |
| Product Code | OYE |
| Date Received | 2017-10-20 |
| 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 | 2017-10-20 |