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 2017-06-22 for AQUIOS CL FLOW CYTOMETER B30166 manufactured by Beckman Coulter Ireland.
[78255021]
Field service was not sent to this account since the instrument was running per specifications. The customer reviewed the results that were being sent to the lis and did not report any erroneous results. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[78255022]
The customer reported problems when re-sending results from the aquios cl flow cytometer to the laboratory information system (lis). The customer made adjustments (modifications) to the primary (original) results of a patient sample, the saved and sent the modified results to the lis (laboratory information system. Later, the customer discarded that result at the lis and re-opened and re-sent the original unadjusted result to the lis. The aquios still sent the adjusted/modified results to the lis. The system operated per specifications; however, the instructions for use (ifu) do not indicate to the customer that only the last modification of the sample result will be sent to the lis, regardless of the display. Erroneous patient results were not reported outside of the laboratory and there was no change or affect to patient treatment in connection to the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1061932-2017-00006 |
| MDR Report Key | 6662031 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-22 |
| Date of Report | 2017-12-06 |
| Date of Event | 2017-05-24 |
| Date Mfgr Received | 2017-07-07 |
| Device Manufacturer Date | 2014-08-01 |
| Date Added to Maude | 2017-06-22 |
| 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, 32-S08 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AQUIOS CL FLOW CYTOMETER |
| Generic Name | AQUIOS CL FLOW CYTOMETER |
| Product Code | OYE |
| Date Received | 2017-06-22 |
| Model Number | NA |
| Catalog Number | B30166 |
| 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 | 2017-06-22 |