MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2011-11-08 for SYNCHRON IRON/IBCT CALIBRATOR FE/IBCT CALIBRATOR 442772 manufactured by Beckman Coulter, Inc..
[2338533]
A beckman coulter, inc. Representative reported on a synchron iron/ibct (total iron building capacity) calibrator leak, due to a loose cap. The reagent was quarantined and no one was affected by the reagent leak.
Patient Sequence No: 1, Text Type: D, B5
[9385585]
The beckman coulter, inc. Identifier for this report is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-07382 |
| MDR Report Key | 2328537 |
| Report Source | 01,07 |
| Date Received | 2011-11-08 |
| Date of Report | 2011-10-12 |
| Date of Event | 2011-10-12 |
| Date Mfgr Received | 2011-10-12 |
| Device Manufacturer Date | 2011-06-24 |
| Date Added to Maude | 2012-07-13 |
| 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 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 928216232 |
| Manufacturer Country | US |
| Manufacturer Postal | 928216232 |
| Manufacturer Phone | 7149614941 |
| Manufacturer G1 | BECKMAN COULTER, INC. |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821623 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 6232 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCHRON IRON/IBCT CALIBRATOR |
| Generic Name | CALIBRATOR, SECONDARY |
| Product Code | CKA |
| Date Received | 2011-11-08 |
| Model Number | FE/IBCT CALIBRATOR |
| Catalog Number | 442772 |
| Lot Number | 58891101 |
| Device Expiration Date | 2012-12-31 |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 250 S. KRAEMER BLVD. BREA CA 92821623 US 92821 6232 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-08 |