MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2011-12-04 for SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGENT CX/LX ALT KIT 76826 manufactured by Beckman Coulter Inc..
[2273873]
The customer contacted beckman coulter inc to report synchron alt 2 x 400 reagent was leaking from unknown source. The customer did not come in contact with the fluid; no exposure (sprayed or splashed) to mucous membranes. No death, injury or changes to patient result or treatment are associated with this event. The reagent is skin, eye and respiratory tract irritant. Contains material of animal origin.
Patient Sequence No: 1, Text Type: D, B5
[9494072]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-08228 |
| MDR Report Key | 2357088 |
| Report Source | 01,06 |
| Date Received | 2011-12-04 |
| Date of Report | 2011-11-02 |
| Date of Event | 2011-11-02 |
| Date Mfgr Received | 2011-11-02 |
| Device Manufacturer Date | 2011-03-01 |
| Date Added to Maude | 2011-12-05 |
| 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 BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGENT |
| Generic Name | NADH OXIDATION/NAD REDUCTION, ALT/SGPT |
| Product Code | CKA |
| Date Received | 2011-12-04 |
| Model Number | CX/LX ALT KIT |
| Catalog Number | 76826 |
| Lot Number | M102143 |
| ID Number | N/A |
| Device Expiration Date | 2012-08-31 |
| Operator | HEALTH PROFESSIONAL |
| 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 BOULEVARD BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-04 |