FDA.reportPublic FDA data

MAUDE MDR 358355

MDR report key
358355
Report number
MW1023212
Event key
0
Event type
3
Date received
2001-10-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1EQUAL -GENZYME- DIRECT LDL REAGENT ON DADE DIMENSION RXLLABORATORY DIAGNOSTIC REAGENTGENZYMELBS***NY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12001-10-2401. O

Event Narratives#

D

Patient 1

DIRECT LDL CHOLESTEROL PERFORMED ON DADE DIMENSION PRODUCES ERRATIC RESULTS. DISTRIBUTOR AWARE OF THIS WITH ANOTHER USER. DID NOT INFORM CLIENTS.