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 CX ALBUMIN REAGENT 442765 manufactured by Beckman Coulter, Inc..
[2396774]
Customer reported that five units of synchron cx albumin reagent leaked upon receipt. No injuries were reported.
Patient Sequence No: 1, Text Type: D, B5
[9600616]
No product was returned for eval, accordingly, no conclusion can be drawn. This is one of five medwatch reports being submitted as the customer reported five individual units were involved. Reference the below mdr numbers for all associated reports: 2050012-2010-00946, 2050012-2011-07407, 2050012-2011-07408, 2050012-2011-07409. This reportable event was identified during a retrospective review of complaints conducted between 01/01/2008 and 10/23/2010 for add'l reportable events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-07406 |
| MDR Report Key | 2393310 |
| Report Source | 05,06 |
| Date Received | 2011-11-15 |
| Date of Report | 2010-09-14 |
| Date of Event | 2010-09-14 |
| Date Mfgr Received | 2010-09-14 |
| Device Manufacturer Date | 2010-03-01 |
| Date Added to Maude | 2012-07-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Removal Correction Number | Z-0863-2010 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON CX ALBUMIN REAGENT |
| Product Code | CKA |
| Date Received | 2011-11-15 |
| Model Number | NA |
| Catalog Number | 442765 |
| Lot Number | M001680 |
| ID Number | NA |
| Device Expiration Date | 2012-03-31 |
| 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 SOUTH KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-15 |