MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-11-15 for SYNCHRON CHOLESTEROL 467825 manufactured by Beckman Coulter, Inc.
[15581342]
Customer reported that the synchron cholesterol reagent container leaked during use on the synchron cx9clinical system. No injuries were reported.
Patient Sequence No: 1, Text Type: D, B5
[15871261]
No device was returned for eval; accordingly, no conclusion can be drawn. This reportable event was identified during a retrospective review of complaints conducted between january 1, 2008 and october 23, 2010 for add'l reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-07361 |
| MDR Report Key | 2393284 |
| Report Source | 05,06 |
| Date Received | 2011-11-15 |
| Date of Report | 2010-09-24 |
| Date of Event | 2010-09-24 |
| Date Mfgr Received | 2010-09-24 |
| Device Manufacturer Date | 2010-03-01 |
| Date Added to Maude | 2012-07-13 |
| 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 S KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON CHOLESTEROL |
| Product Code | CHH |
| Date Received | 2011-11-15 |
| Model Number | NA |
| Catalog Number | 467825 |
| Lot Number | M912543 |
| ID Number | NA |
| Device Expiration Date | 2011-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2011-11-15 |