MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2011-05-26 for SYNCHRON CX ALT REAGENT KIT 442620 manufactured by Beckman Coulter Inc..
[2146798]
A distributor reported to beckman coulter inc. (bci) that the bottom of synchron cx alt reagent cartridge was leaking through the seam. No injury was reported for this event.
Patient Sequence No: 1, Text Type: D, B5
[9019413]
Product was quarantined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-01914 |
| MDR Report Key | 2104390 |
| Report Source | 01,08 |
| Date Received | 2011-05-26 |
| Date of Report | 2011-04-28 |
| Date of Event | 2011-04-28 |
| Date Mfgr Received | 2011-04-28 |
| Device Manufacturer Date | 2011-01-17 |
| 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 | 3 |
| 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 BOULEVARD |
| Manufacturer City | BREA CA 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 CX ALT REAGENT KIT |
| Generic Name | ALANINE AMINOTRANSFERASE REAGENT |
| Product Code | CKA |
| Date Received | 2011-05-26 |
| Model Number | NA |
| Catalog Number | 442620 |
| Lot Number | M012323 |
| Device Expiration Date | 2012-07-31 |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER INC. |
| Manufacturer Address | 250 S KRAEMER BOULEVARD BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-26 |