MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-06-25 for ASPARTATE AMINOTRANSFERASE REAGENT AST KIT 476831 manufactured by Beckman Coulter Inc..
[2069483]
A customer contacted beckman coulter inc. (bci) to report a aspartate aminotransferase (ast) cartridge leak from the bottom seam. The customer wore ppe and cleaned up the puddle and disposed the cartridge. No injury was reported or occurred due to this event.
Patient Sequence No: 1, Text Type: D, B5
[9166662]
Replacement reagent was sent to the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-02643 |
| MDR Report Key | 2140114 |
| Report Source | 06 |
| Date Received | 2011-06-25 |
| Date of Report | 2011-05-25 |
| Date of Event | 2011-05-25 |
| Date Mfgr Received | 2011-05-25 |
| Device Manufacturer Date | 2010-11-24 |
| Date Added to Maude | 2012-03-27 |
| 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 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 | RL |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASPARTATE AMINOTRANSFERASE REAGENT |
| Generic Name | ASPARTATE AMINOTRANSFERASE REAGENT |
| Product Code | CKA |
| Date Received | 2011-06-25 |
| Model Number | AST KIT |
| Catalog Number | 476831 |
| Lot Number | M011497 |
| ID Number | N/A |
| Device Expiration Date | 2012-05-31 |
| 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 BLVD BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-25 |