MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2007-05-11 for CLINICAL CHEMISTRY AST-ACTIVATED 8D37-30 manufactured by Abbott Laboratories.
[17726287]
The customer stated, that two of the aspartate aminotransferase activated (asta) reagents with the lot# 46059hw00 has incorrect top labeling with the short-name alta instead of asta. There was no impact or patient management reported.
Patient Sequence No: 1, Text Type: D, B5
[18009865]
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 | 2018433-2007-00023 |
| MDR Report Key | 967167 |
| Report Source | 01,05 |
| Date Received | 2007-05-11 |
| Date of Report | 2007-05-07 |
| Date of Event | 2007-03-19 |
| Date Mfgr Received | 2007-05-07 |
| Date Added to Maude | 2007-12-20 |
| 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 | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 936913 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 820 MISSION ST. SOUTH PASADENA CA 91030 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-05-11 |