MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-12-15 for AXSYM * manufactured by Abbott Laboratories.
[73351]
Pt was admitted to hosp with overdose of accolate & theodur. Therapeutic drug analyzer malfunctioned thus theophyllin level not determined until device was repaired. Meanwhile, pt had a grand mal seizure. Therapeutic drugs/interventions were implemented and pt responded satisfactorily.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 139556 |
| MDR Report Key | 139556 |
| Date Received | 1997-12-15 |
| Date of Report | 1997-12-09 |
| Date of Event | 1997-11-17 |
| Date Facility Aware | 1997-11-17 |
| Report Date | 1997-12-09 |
| Date Added to Maude | 1997-12-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXSYM |
| Generic Name | THERAPEUTIC DRUG ANALYZER |
| Product Code | KLS |
| Date Received | 1997-12-15 |
| Model Number | AXSYM |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 136257 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK RD ABBOTT PARK IL 600643500 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-12-15 |