FDA.reportPublic FDA data

MAUDE MDR 4362484

MDR report key
4362484
Report number
2247117-2014-00092
Event key
0
Event type
3
Date of event
2014-11-14
Date received
2014-12-26
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 2000 XPIIMMULITE 2000 XPISIEMENS HEALTHCARE DIAGNOSTICS INC.JJQIMMULITE 2000 XPI030001-03N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-12-260

Event Narratives#

D

Patient 1

THE CUSTOMER HAS OBTAINED A FALSE NEGATIVE RESULT ON ONE PATIENT SAMPLE FOR SYPHILIS ON AN IMMULITE 2000 XPI INSTRUMENT. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT AND REQUESTED A RETEST OF THE SAMPLE. THE SAMPLE WAS REPEATED ON ANOTHER IMMULITE 2000 XPI INSTRUMENT AND THE RESULT WAS POSITIVE. THIS RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSE NEGATIVE SYPHILIS RESULT.

N

Patient 1

A SIEMENS HEADQUARTERS SUPPORT SPECIALIST (HSC) REVIEWED THE INSTRUMENT FILES. SINCE THE TIME THE DISCORDANTS WERE OBTAINED ON THE IMMULITE 2000 XPI, THE CUSTOMER HAS INSTALLED A NEW IMMULITE 2000 XPI. AS A RESULT THE INSTRUMENT FILES DURING THE TIME THE FALSE NEGATIVE RESULT WAS OBTAINED COULD NOT BE EVALUATED. BASED ON THE INSTRUMENT FILES RECEIVED HSC DID INFORM THE CUSTOMER THAT MULTIPLE SAMPLES WERE TESTED FOR SYPHILIS AT THE SAME TIME THE FALSE NEGATIVE WAS OBTAINED ON THE ONE PATIENT SAMPLE. THE OTHER SAMPLES WERE NOT REPORTED AS DISCORDANTS. THE CAUSE OF THE FALSE NEGATIVE RESULT ON THE PATIENT SAMPLE IS UNKNOWN. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.