MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-05-10 for SYNCHRON? CK 2 X 400 476836 manufactured by Beckman Coulter, Inc..
[20412483]
A customer contacted beckman coulter inc. (bci) in regards to fluid leaks from synchron ck and synchron dbil reagent cartridges on unicel dxc 800 synchron clinical system. No injury was reported and there was no exposure to uncovered wounds or mucous membranes.
Patient Sequence No: 1, Text Type: D, B5
[20590477]
Replacement reagent was sent to the customer. Note: the product information on the other reagent involved in this event, synchron dbil reagent, is listed below: part number: 476856, lot number: m01518, date of manufacture: 11/17/2010, expiration date: 11/30/2012, product code: jfm, 510(k): k934068.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-01597 |
| MDR Report Key | 2083663 |
| Report Source | 06 |
| Date Received | 2011-05-10 |
| Date of Report | 2011-04-13 |
| Date of Event | 2011-04-13 |
| Date Mfgr Received | 2011-04-13 |
| Device Manufacturer Date | 2011-03-18 |
| Date Added to Maude | 2012-02-10 |
| 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 BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| 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 | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON? CK 2 X 400 |
| Generic Name | CREATINE KINASE REAGENT |
| Product Code | CKA |
| Date Received | 2011-05-10 |
| Model Number | NA |
| Catalog Number | 476836 |
| Lot Number | M101637 |
| ID Number | NA |
| Device Expiration Date | 2012-01-31 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2011-05-10 |