MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2011-04-21 for DXC 800 PRO REAGENT N/A 442665 manufactured by Beckman Coulter Inc..
[19661437]
A customer contacted beckman coulter inc. (bci) to report that one (1) dxc 800 pro ast reagent pack leaked all out on arrival. Reagent pack was empty. No effect to user was reported with this event.
Patient Sequence No: 1, Text Type: D, B5
[19750582]
A replacement was sent to the customer. A clear root cause is unknown at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-01045 |
| MDR Report Key | 2066337 |
| Report Source | 01 |
| Date Received | 2011-04-21 |
| Date of Report | 2011-03-22 |
| Date of Event | 2011-03-22 |
| Date Mfgr Received | 2011-03-22 |
| Device Manufacturer Date | 2010-10-28 |
| Date Added to Maude | 2011-05-03 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. NORA ZEROUNIAN |
| Manufacturer Street | 250 S KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER INC. |
| Manufacturer Street | 250 S KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DXC 800 PRO REAGENT |
| Generic Name | DXC 800 PRO REAGENT |
| Product Code | CKA |
| Date Received | 2011-04-21 |
| Model Number | N/A |
| Catalog Number | 442665 |
| Lot Number | T010139 |
| Device Expiration Date | 2012-04-30 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER INC. |
| Manufacturer Address | 250 S KRAEMER BOULEVARD BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-21 |