MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-12-19 for SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT 442785 manufactured by Beckman Coulter, Inc..
[2499706]
On (b)(6), 2011 customer reported that they received a cartridge of uric acid that was leaking from the base. No injuries or exposure were reported. Beckman coulter sent a replacement.
Patient Sequence No: 1, Text Type: D, B5
[9576882]
Beckman coulter identifier for this report is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-08480 |
| MDR Report Key | 2381373 |
| Report Source | 01,05,06 |
| Date Received | 2011-12-19 |
| Date of Report | 2011-11-22 |
| Date of Event | 2011-11-22 |
| Date Mfgr Received | 2011-11-22 |
| Device Manufacturer Date | 2011-08-03 |
| Date Added to Maude | 2012-07-25 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. DUNG NGUYEN |
| Manufacturer Street | 250 SOUTH KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT |
| Generic Name | ACID, URIC, URICASE (COLORIMETRIC) |
| Product Code | KNK |
| Date Received | 2011-12-19 |
| Catalog Number | 442785 |
| Lot Number | M106422 |
| Device Expiration Date | 2013-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 SOUTH KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-19 |