MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2007-05-11 for CLINICAL CHEMISTRY AST-ACTIVATED 8D37-30 manufactured by Abbott Mfg, Inc.
[765369]
The customer stated that she received the aspartate aminotransferase activated (asta) reagent and found conflicting labeling and is questioning which label is correct. Alta or asta? There was no impact to patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[8088122]
This is an initial report. An investigation is in process. A final report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2018433-2007-00021 |
| MDR Report Key | 967371 |
| Report Source | 01 |
| Date Received | 2007-05-11 |
| Date of Report | 2007-05-07 |
| Date of Event | 2007-03-20 |
| Date Mfgr Received | 2007-05-07 |
| Date Added to Maude | 2007-12-21 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | DR. DAVID BARCH, D-09Y6, AP6C-2 |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600646092 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646092 |
| Manufacturer Phone | 8479379328 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | 2018433-4/13/07-002-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINICAL CHEMISTRY AST-ACTIVATED |
| Generic Name | QUANTITATION OF ASPARTATE AMINOTRANSFERASE |
| Product Code | CIT |
| Date Received | 2007-05-11 |
| Model Number | NA |
| Catalog Number | 8D37-30 |
| Lot Number | 46059HW00 |
| ID Number | NA |
| Device Expiration Date | 2007-10-27 |
| Operator | UNKNOWN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 937059 |
| Manufacturer | ABBOTT MFG, INC |
| Manufacturer Address | 820 MISSION ST. SOUTH PASADENA CA 91030 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-05-11 |