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 2017-11-03 for AQUIOS CL FLOW CYTOMETER B30166 NA manufactured by Beckman Coulter Ireland Inc..
[92211496]
The customer provided screen shots of the instrument settings and logs that were used for a preliminary assessment of the event. The beckman coulter (bec) software engineering team reviewed the available information and found two sample id numbers that are suspected to be erroneous ((b)(6)). Additional software data has been requested for a comprehensive assessment of the issue.. On (b)(6) 2017, the customer was contacted via telephone to discuss the event and inform them of the two potential sample misidentifications. The customer (dr. (b)(6)) reviewed his records and confirmed that the results for patient id (b)(6) were reviewed as correct and that the results for patient id (b)(6) had been considered incorrect upon review and the patient sample was rerun. The original erroneous result was not reported out of the lab. In the same conversation the customer has agreed to allow a bec software specialist to access their database for further assessment. The bec software specialist is scheduled to go to the customer site the week of november 06, 2017. Additional software data has been requested from the customer in order to complete a comprehensive assessment of the issue. Based on the information available, the assignable cause is an aquios cl software malfunction. Patient age is unknown. Patient sex is unknown. Patient weight is unknown. Patient ethnicity is unknown. Patient race is unknown. Bec internal identifier - (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[92211497]
The customer reported that the laboratory had followed the field safety notice fsn-31978 instructions and updated the instrument settings on (b)(6) 2017. The customer reported duplicate sample requests being generated by their aquios cl on (b)(6) 2017, and that it seems the change to the settings was not effective. The customer did not identify any erroneous results at the time of discovery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1061932-2017-00017 |
| MDR Report Key | 7000643 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-11-03 |
| Date of Report | 2017-10-24 |
| Date of Event | 2017-10-20 |
| Date Mfgr Received | 2017-10-24 |
| Device Manufacturer Date | 2014-08-01 |
| Date Added to Maude | 2017-11-03 |
| 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 | 2017-11-03 |
| 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 CA EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-03 |