MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,06 report with the FDA on 2013-08-05 for PREP PLUS 2 WORKSTATION 378600 manufactured by Beckman Coulter.
[3635456]
The affiliate stated the customer reported that the flow count fluorospheres holder on the preplus 2 workstation was not mixing the flow-count plate. Patient samples were not analyzed at the time of the event. No patient results were generated. There was no patient consequence associated with this event. A beckman coulter field service engineer (fse) was dispatched to assess the instrument.
Patient Sequence No: 1, Text Type: D, B5
[10980659]
The field service engineer (fse) stated the flow-count mixing/holder was not mixing properly. The instrument component is currently in order. The component has not been replaced.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2013-01670 |
| MDR Report Key | 3263139 |
| Report Source | 00,01,06 |
| Date Received | 2013-08-05 |
| Date of Report | 2013-07-08 |
| Date of Event | 2013-07-08 |
| Date Mfgr Received | 2013-07-08 |
| Device Manufacturer Date | 1994-03-24 |
| Date Added to Maude | 2013-10-30 |
| 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 | SERVICE PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. DUNG NGUYEN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PREP PLUS 2 WORKSTATION |
| Generic Name | AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTO |
| Product Code | PER |
| Date Received | 2013-08-05 |
| Model Number | NA |
| Catalog Number | 378600 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-05 |