MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2011-12-20 for SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) CALIBRATOR 969739 manufactured by Beckman Coulter Inc..
[2499749]
Beckman coulter eurocenter in italy reported that they received cx/lx c-rp cal kit bottles leaking due to loose caps. No injury was reported due to the exposure.
Patient Sequence No: 1, Text Type: D, B5
[9573789]
Inventory has been transferred to quarantine sub-inventory. No additional information is available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-08455 |
| MDR Report Key | 2383192 |
| Report Source | 01,08 |
| Date Received | 2011-12-20 |
| Date of Report | 2011-11-18 |
| Date of Event | 2011-11-18 |
| Date Mfgr Received | 2011-11-18 |
| Device Manufacturer Date | 2011-06-07 |
| Date Added to Maude | 2011-12-21 |
| 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. 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 INC. |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) CALIBRATOR |
| Generic Name | C-REACTIVE PROTEIN (C-RP) CALIBRATOR |
| Product Code | JIS |
| Date Received | 2011-12-20 |
| Model Number | NA |
| Catalog Number | 969739 |
| Lot Number | M101480 |
| ID Number | NA |
| Device Expiration Date | 2013-03-31 |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER INC. |
| Manufacturer Address | 250 S KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-20 |