MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01 report with the FDA on 2011-11-01 for LITHIUM TEST KIT A19611 manufactured by Beckman Coulter, Inc..
[2222275]
On (b)(6) 2011, the beckman coulter site in (b)(6) reported that they received a bottle of lithium reagent that had leaked. There was no exposure or injury to the operator. Upon recur, it is unknown if serious injury could occur, so it was determined that an mdr should be filed for this event.
Patient Sequence No: 1, Text Type: D, B5
[9479485]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-07057 |
| MDR Report Key | 2318281 |
| Report Source | 00,01 |
| Date Received | 2011-11-01 |
| Date of Report | 2011-10-05 |
| Date of Event | 2011-10-05 |
| Date Mfgr Received | 2011-10-05 |
| Device Manufacturer Date | 2010-11-10 |
| Date Added to Maude | 2012-07-11 |
| 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. DUNG NGUYEN |
| Manufacturer Street | 250 SOUTH KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 2470 FARADAY AVE. |
| Manufacturer City | CARLSBAD CA 92010 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92010 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LITHIUM TEST KIT |
| Generic Name | ASSAY, PORPHYRIN, SPECTROPHOTOMETRY, LITHIUM |
| Product Code | NDW |
| Date Received | 2011-11-01 |
| Catalog Number | A19611 |
| Lot Number | M010761 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2011-11-01 |