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 2011-10-07 for SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT 442785 manufactured by Beckman Coulter, Inc..
[20087412]
On (b)(6) 2011, customer reported that they received a broken cartridge of uric acid. No exposure or injuries were reported. Since it is unclear which compartment of the cartridge leaked, and in the event it was compartment b, which contains materials of animal origin and upon recur it could potentially expose persons to infectious diseases, it was decided that an mdr should be filed.
Patient Sequence No: 1, Text Type: D, B5
[20206616]
Cartridge was cracked. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-06037 |
| MDR Report Key | 2282684 |
| Report Source | 01,05,06 |
| Date Received | 2011-10-07 |
| Date of Report | 2011-09-14 |
| Date of Event | 2011-09-14 |
| Date Mfgr Received | 2011-09-14 |
| Device Manufacturer Date | 2011-04-28 |
| Date Added to Maude | 2011-10-19 |
| 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. NORA ZEROUNIAN |
| Manufacturer Street | 250 SOUTH KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 2470 FARADAY AVE. |
| Manufacturer City | CARLSBAD 92010 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92010 |
| 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 | 2011-10-07 |
| Catalog Number | 442785 |
| Lot Number | M104187 |
| Device Expiration Date | 2012-10-31 |
| 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 | 2011-10-07 |