MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2011-07-02 for ALANINE AMINO TRANSFERASE (ALT/SGPT) TEST SYSTEM. N/A 442620 manufactured by Beckman Coulter Inc..
[2068261]
A beckman coulter inc (bec) (b)(4) reported receiving alanine amino transferase (alt) cartridge which had leaked. Personal protective equipment was used when handling the cartridge. No injury or exposures were reported.
Patient Sequence No: 1, Text Type: D, B5
[9200182]
No additional information is available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-02644 |
| MDR Report Key | 2148203 |
| Report Source | 01,07 |
| Date Received | 2011-07-02 |
| Date of Report | 2011-06-01 |
| Date of Event | 2011-06-01 |
| Date Mfgr Received | 2011-06-01 |
| Device Manufacturer Date | 2011-03-04 |
| Date Added to Maude | 2012-03-14 |
| 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 | NADH OXIDATION/NAD REDUCTION, ALT/SGPT |
| Product Code | CKA |
| Date Received | 2011-07-02 |
| Model Number | N/A |
| Catalog Number | 442620 |
| Lot Number | M102250 |
| ID Number | N/A |
| Device Expiration Date | 2012-09-30 |
| Operator | SERVICE PERSONNEL |
| 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 BOULEVARD BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-07-02 |