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 |