FDA.reportPublic FDA data

MAUDE MDR 1987011

MDR report key
1987011
Report number
2432235-2011-00024
Event key
0
Event type
3
Date of event
2011-02-07
Date received
2011-02-14
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
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 2000IMMUNOASSAY ANALYZER, PRODUCT CODE:SIEMENS HEALTHCARE DIAGNOSTICSDGCIMMULITE 2000030002N/AN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-02-140

Event Narratives#

D

Patient 1

A DISCORDANT IMMULITE 2000 GASTRIN RESULT WAS OBTAINED ON A PATIENT SAMPLE.THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. UPON RETEST THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN. THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT GASTRIN RESULT.

N

Patient 1

A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT GASTRIN RESULT WAS DUE TO A MISALIGNED DILUTION WELL BOTTOM. THE FSE READJUSTED THE DILUTION WELL AND RAN QC.THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.