MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-02-19 for ALKALINE PHOSPHATASE (ALP) 476821 manufactured by Beckman Coulter Inc..
[1968583]
A customer contacted beckman coulter inc. , (bci) and reported that an alkaline phosphatase (alp) reagent leaked due to a crack on the seam of the cartridge. No injury was reported on this issue.
Patient Sequence No: 1, Text Type: D, B5
[8951933]
Customer was sent replacement.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-00343 |
| MDR Report Key | 1996717 |
| Report Source | 07 |
| Date Received | 2011-02-19 |
| Date of Report | 2011-01-25 |
| Date of Event | 2011-01-24 |
| Date Mfgr Received | 2011-01-25 |
| Device Manufacturer Date | 2010-10-14 |
| 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 | 0 |
| 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 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 0 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALKALINE PHOSPHATASE (ALP) |
| Generic Name | ALKALINE PHOSPHATASE (ALP) |
| Product Code | CJE |
| Date Received | 2011-02-19 |
| Model Number | NA |
| Catalog Number | 476821 |
| Lot Number | Z010012 |
| 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 | 2011-02-19 |