MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-01-25 for ETHANOL KIT ETOH KIT 447280(RGT) & 657365(CONTROL) manufactured by Beckman Coulter Inc..
[1897255]
A customer contacted beckman coulter inc. (bci) in regards to one ethanol (etoh) reagent kit leak. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[8969452]
No information is available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-00223 |
| MDR Report Key | 1970645 |
| Report Source | 05 |
| Date Received | 2011-01-25 |
| Date of Report | 2010-12-29 |
| Date of Event | 2010-12-29 |
| Date Mfgr Received | 2010-12-29 |
| Device Manufacturer Date | 2010-04-14 |
| Date Added to Maude | 2012-01-26 |
| 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 BLVD |
| 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 | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETHANOL KIT |
| Generic Name | ETHANOL KIT 2X150 TEST |
| Product Code | DKC |
| Date Received | 2011-01-25 |
| Model Number | ETOH KIT |
| Catalog Number | 447280(RGT) & 657365(CONTROL) |
| Lot Number | M004395 |
| ID Number | N/A |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2011-01-25 |