FDA.reportPublic FDA data

MAUDE MDR 4804332

MDR report key
4804332
Report number
2247117-2015-00029
Event key
0
Event type
3
Date of event
2015-04-30
Date received
2015-05-29
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
AARTI AZIZ
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 2000IMMULITE 2000SIEMENS HEALTHCARE DIAGNOSTICS INC.JJQIMMULITE 200030002N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-05-290

Event Narratives#

D

Patient 1

THE CUSTOMER HAS OBTAINED A FALSE NEGATIVE RESULT ON ONE PATIENT SAMPLE FOR HUMAN CHORIONIC GONADOTROPIN (HCG) ON AN IMMULITE 2000 INSTRUMENT. THE PATIENT SAMPLE WAS THEN REPEATED ON THE SAME IMMULITE 2000 INSTRUMENT AND THE RESULT WAS POSITIVE AND IN ALIGNMENT WITH THE CLINICAL PICTURE OF THE PATIENT. IT IS UNKNOWN IF THE INITIAL OR THE REPEATED RESULT FOR HCG WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO FALSE NEGATIVE HCG RESULT.

N

Patient 1

A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST EVALUATED THE INSTRUMENT FILES PROVIDED BY THE CUSTOMER. HSC DID NOT FIND ANY SPECIFIC ERRORS ON THE INSTRUMENT THAT COULD BE RELATED TO THE DISCORDANT FALSE NEGATIVE SAMPLE AT THAT TIME IT WAS BEING RUN ON THE INSTRUMENT. THE CAUSE OF THE FALSE NEGATIVE HCG RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.