FDA.reportPublic FDA data

MAUDE MDR 2162539

MDR report key
2162539
Report number
2247117-2011-00041
Event key
0
Event type
3
Date of event
2011-06-09
Date received
2011-07-14
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
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 DIAGNOSTICS INC.DGCIMMULITE 200010380062N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-07-140

Event Narratives#

D

Patient 1

A DISCORDANT LOW GASTRIN (GAS) RESULT WAS OBTAINED FOR ONE (1) PATIENT SAMPLE ON AN IMMULITE 2000. THE LABORATORY QUESTIONED THE INITIAL LOW RESULT AND THE SAMPLE WAS RE-TESTED TWICE. THE REPEAT GAS RESULTS WERE HIGHER AND WERE REPORTED. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT GAS RESULT.

N

Patient 1

A SIEMENS HEALTHCARE DIAGNOSTICS INC. FSE (FIELD SERVICE ENGINEER) WAS SENT TO THE CUSTOMER SITE. THE FSE COMPLETED AN INSPECTION WHICH INCLUDED CHECKING DISPENSE VOLUMES, SPINNER SPEEDS (BOTH WASH AND DILUTION WELL), TEMPERATURES AND SAMPLE AND REAGENT PIPETTOR POSITIONS. THE FSE ALSO RAN A PRECISION RUN ON GASTRIN USING ALL THREE LEVELS OF CONTROLS. THE PRECISION RESULTS WERE WITHIN SPECIFICATIONS. AFTER ANALYSIS OF THE SYSTEM AND SYSTEM DATA, THE ACTUAL CAUSE COULD NOT BE DETERMINED AND NO CONCLUSION CAN BE DRAWN AS TO WHAT SPECIFICALLY CAUSED THE PROBLEM. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS AND NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.