FDA.reportPublic FDA data

MAUDE MDR 2049045

MDR report key
2049045
Report number
2247117-2011-00021
Event key
0
Event type
3
Date of event
2011-03-16
Date received
2011-04-11
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
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 DIAGNOSTICSDGCN/A030002N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-04-110

Event Narratives#

D

Patient 1

MULTIPLE DISCORDANT HIGH IMMULITE 2000 INS AND TSH RESULTS WERE GENERATED FOR MULTIPLE PATIENTS. ONE PATIENT ((B)(6) BOY) WITH A DISCORDANT HIGH TSH RESULT WAS KEPT OVERNITE IN THE HOSPITAL FOR FURTHER TESTING. NO MEDICAL PROCEDURE WAS PERFORMED ON THE BOY. THE LABORATORY REPEATED THE SAMPLES AND THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE WAS NO KNOWN REPORT OF TREATMENT GIVEN OR WITHHELD BASED ON THE DISCORDANT INS AND TSH RESULTS.

N

Patient 1

A SIEMENS FSE (FIELD SERVICE ENGINEER) ANALYZED THE IMMULITE 2000 INSTRUMENT AND INSTRUMENT DATA. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATED THAT THE CAUSE FOR THE DISCORDANT INS AND TSH RESULTS WAS DUE TO A MALFUNCTION OF THE WATER PUMP. THE WATER PUMP WAS REPLACED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.