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 2017-07-11 for AQUIOS CL FLOW CYTOMETER B30166 manufactured by Beckman Coulter Ireland.
[79767342]
Field service was sent to this account for an issue regarding the probe. While on site the field service engineer (fse) found that the instrument was not configured properly. The fse reconfigured the instrument to the proper status. The repairs were verified. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[79767343]
The customer reported the aquios cl flow cytometer was generating erroneous results on an unknown number of cd4 samples. The customer initially reported a bent probe. The field service engineer found the system was not configured properly and was generating erroneous results. Erroneous patient results were reported outside of the laboratory, however, there was no change or affect to patient treatment in connection to the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1061932-2017-00008 |
| MDR Report Key | 6703630 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-07-11 |
| Date of Report | 2017-09-22 |
| Date of Event | 2017-05-22 |
| Date Mfgr Received | 2017-09-22 |
| Device Manufacturer Date | 2016-04-01 |
| Date Added to Maude | 2017-07-11 |
| 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 |
| Removal Correction Number | Z-3135-2017 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AQUIOS CL FLOW CYTOMETER |
| Generic Name | FLOW CYTOMETER |
| Product Code | OYE |
| Date Received | 2017-07-11 |
| 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 | 2017-07-11 |