FDA.reportPublic FDA data

MAUDE MDR 139556

MDR report key
139556
Report number
139556
Event key
0
Event type
3
Date of event
1997-11-17
Date received
1997-12-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1AXSYMTHERAPEUTIC DRUG ANALYZERABBOTT LABORATORIESKLSAXSYM**NY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11997-12-1501. R

Event Narratives#

D

Patient 1

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.