FDA.reportPublic FDA data

MAUDE MDR 1874233

MDR report key
1874233
Report number
2247117-2010-00043
Event key
0
Event type
3
Date of event
2010-09-22
Date received
2010-10-12
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
LINDA BARLETTA
Address
511 BENEDICT AVE TARRYTOWN NY 10591 US
Phone
914-914-9145
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1IMMULITE 2000IMMUNO-ASSAYSIEMENS HEALTHCARE DIAGNOSTICS INC.DGCNA030002NAN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-10-120

Event Narratives#

D

Patient 1

A DISCORDANT LOW IMMULITE 2000 CA15-3 RESULT WAS OBTAINED FOR ONE (1) PT SAMPLE. THE PHYSICIAN QUESTIONED THE RESULT DUE TO THE PT'S HISTORY, AND THE SAMPLE WAS RE-TESTED. PT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA15-3 RESULTS.

N

Patient 1

A SIEMENS HEALTHCARE TECHNICAL SERVICE ENGINEER (TSE) EVALUATED THE IMMULITE 2000 INSTRUMENT DATA. THE TSE CONCLUDED THAT THE CAUSE OF THE DISCREPANT CA15-3 RESULTS IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.