FDA.reportPublic FDA data

MAUDE MDR 4268992

MDR report key
4268992
Report number
2247117-2014-00081
Event key
0
Event type
3
Date of event
2014-10-28
Date received
2014-11-21
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
CASSANDRA KOCSIS
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 2000 XPIIMMULITE 2000 XPISIEMENS HEALTHCARE DIAGNOSTICS INC.JJQIMMULITE 2000 XPI030001-03N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-11-210

Event Narratives#

D

Patient 1

DISCORDANT, FALSELY LOW ALPHAFETO PROTIEN (AFP), HUMAN CHORIONIC GONADATROPIN (HCG) AND UNCONJUGATED ESTRIOL (UE3) RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT. THE FALSELY LOW AFP, HCG AND UE3 RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED ON SAME INSTRUMENT AND RESULTED HIGHER THAN THE INITIAL LOW RESULTS. THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW AFP, HCG AND UE3 RESULTS.

N

Patient 1

A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE EVALUATED THE INSTRUMENT, INCLUDING SAMPLE PIPETTING, FLUIDS, LEVEL SENSING AND THE GROUNDING OF THE SAMPLE CAROUSEL, AND DID NOT FIND AN INSTRUMENT MALFUNCTION. A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST REVIEWED THE INSTRUMENT DATA. THE QUALITY CONTROLS FOR ALL LEVELS AND ADJUSTMENTS FOR ALL THREE ASSAYS WERE WITHIN ACCEPTABLE RANGES. THE CAUSE OF DISCORDANT, FALSELY LOW AFP, HCG AND UE3 RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.