FDA.reportPublic FDA data

MAUDE MDR 2042501

MDR report key
2042501
Report number
2247117-2011-00019
Event key
0
Event type
3
Date of event
2011-03-16
Date received
2011-04-06
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 AVENUE 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 DIAGNOSTICSDGCN/A030002N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-04-060

Event Narratives#

D

Patient 1

THREE DISCORDANT LOW IMMULITE 2000 HCG RESULTS AND ONE UE3 RESULT WAS OBTAINED ON THREE (3) PATIENT SAMPLES. THE LABORATORY REPEATED THE SAMPLES AND THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE WAS NO REPORT OF TREATMENT GIVEN OR WITHHELD BASED ON THE DISCORDANT HCG AND UE3 RESULTS.

N

Patient 1

A SIEMENS FSE (FIELD SERVICE ENGINEER) ANALYZED THE IMMULITE 2000 INSTRUMENT AND INSTRUMENT DATA. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATES THAT THE CAUSE FOR THE DISCORDANT HCG AND UE3 RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.