FDA.reportPublic FDA data

MAUDE MDR 5057454

MDR report key
5057454
Report number
2247117-2015-00048
Event key
0
Event type
3
Date of event
2015-08-03
Date received
2015-09-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

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 XPI030001-03N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-09-040

Event Narratives#

N

Patient 1

A SIEMENS FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE. THE FSE CARRIED OUT ROUTINE ADJUSTMENTS AND ALIGNMENTS AND ALSO PERFORMED THE MONTHLY MAINTENANCE ON THE SYSTEM. QUALITY CONTROL SAMPLES WERE THEN RUN ON THE SYSTEM IN MULTIPLE REPLICATES AND ALL VALUES WERE WITHIN SPECIFICATIONS. THE CAUSE OF THE FALSELY LOW RESULTS FOR GASTRIN IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

D

Patient 1

THE CUSTOMER HAS OBTAINED A FALSELY LOW RESULT ON A PATIENT SAMPLE FOR THE GASTRIN ASSAY ON AN IMMULITE 2000 XPI INSTRUMENT. THE GASTRIN RESULT ON THE SAMPLE WAS LOW COMPARED TO WHAT THE CUSTOMER EXPECTED. THE SAME SAMPLE WAS REPEATED ON ANOTHER IMMULITE 2000 XPI INSTRUMENT IN THE SAME LABORATORY AND THE RESULT WAS HIGHER (ABOVE ANALYTICAL RANGE). THE CUSTOMER DILUTED THE SAMPLE 1:10 AND THE RESULT OBTAINED ON THE SECOND IMMULITE INSTRUMENT WAS ACCEPTABLE. THE INITIAL FALSELY LOW RESULT WAS REPORTED TO THE PHYSICIAN(S). THE REPEAT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY LOW GASTRIN RESULT.