MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2011-08-05 for ALANINE AMINO TRANSFERASE (ALT/SGPT) TEST SYSTEM. ALT REAGENT 442620 manufactured by Beckman Coulter Inc..
[15504368]
A customer contacted beckman coulter inc (bec) to report alanine amino transferase (alt) reagent leaked from the bottom cartridge. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[15723758]
Replacement alt reagent was sent to the customer. Bec internal identification number is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-03903 |
| MDR Report Key | 2194014 |
| Report Source | 01,06,07 |
| Date Received | 2011-08-05 |
| Date of Report | 2011-07-12 |
| Date of Event | 2011-07-12 |
| Date Mfgr Received | 2011-07-12 |
| Device Manufacturer Date | 2011-01-17 |
| Date Added to Maude | 2012-04-27 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS NORA ZEROUNIAN |
| Manufacturer Street | 250 S KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER INC. |
| Manufacturer Street | 250 S KRAEMER BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALANINE AMINO TRANSFERASE (ALT/SGPT) TEST SYSTEM. |
| Generic Name | ALANINE AMINO TRANSFERASE (ALT/SGPT) TEST SYSTEM |
| Product Code | CKA |
| Date Received | 2011-08-05 |
| Model Number | ALT REAGENT |
| Catalog Number | 442620 |
| Lot Number | M012323 |
| ID Number | N/A |
| Device Expiration Date | 2012-07-31 |
| Operator | SERVICE PERSONNEL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER INC. |
| Manufacturer Address | 250 S KRAEMER BOULEVARD BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-05 |