MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-05-19 for SYNCHRON ? CX3 DELTA CLINICAL SYSTEM. 467501 manufactured by Beckman Coulter Inc..
[2145674]
A customer contacted beckman coulter inc. (bci) in regards to creatinine reaction cup leak on the synchron cx3 delta clinical system not calibrating. No injury was reported for this event.
Patient Sequence No: 1, Text Type: D, B5
[9003476]
The customer canceled the service request. On (b)(4) 2011, qa followed-up with the customer. The customer suspected that she did not tighten the reaction cup when she performed weekly maintenance. The customer re-run the weekly maintenance and tighten the reaction and issue was resolved.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-01838 |
| MDR Report Key | 2095659 |
| Report Source | 06 |
| Date Received | 2011-05-19 |
| Date of Report | 2011-04-17 |
| Date of Event | 2011-04-17 |
| Date Mfgr Received | 2011-04-17 |
| Device Manufacturer Date | 2006-03-24 |
| Date Added to Maude | 2011-07-21 |
| 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. NORA ZEROUNIAN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613436 |
| Manufacturer G1 | BECKMAN COULTER INC. |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON ? CX3 DELTA CLINICAL SYSTEM. |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJF |
| Date Received | 2011-05-19 |
| Model Number | CX3 DELTA |
| Catalog Number | 467501 |
| Lot Number | N/A |
| ID Number | N/A |
| Device Availability | Y |
| 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 | 2011-05-19 |