FDA.reportPublic FDA data

MAUDE MDR 2939976

MDR report key
2939976
Report number
2432235-2013-00046
Event key
0
Event type
3
Date of event
2012-01-14
Date received
2013-02-01
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
1COAT-A-COUNT FREE TESTOSTERONECOAT-A-COUNT FREE TESTOSTERONESIEMENS HEALTHCARE DIAGNOSTICSGKLCOAT-A-COUNT FREE TESTOSTERONETKTF1458; 1462; 1463N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-02-010

Event Narratives#

D

Patient 1

DISCORDANT, FALSELY LOW FREE TESTOSTERONE RESULTS WERE OBTAINED ON PATIENT SAMPLES ON AN RIA INSTRUMENT USING COAT-A-COUNT FREE TESTOSTERONE LOTS 1458, 1462, AND 1463. IT IS UNKNOWN IF THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE RERUN AT A REFERENCE LABORATORY, AND HIGHER RESULTS WERE OBTAINED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY LOW FREE TESTOSTERONE RESULTS.

N

Patient 1

THE CAUSE OF THE DISCORDANT, FALSELY LOW FREE TESTOSTERONE RESULTS IS UNKNOWN. SIEMENS IS INVESTIGATING THIS ISSUE.

N

Patient 1

THE INITIAL MDR 2432235-2013-00046 WAS FILED ON FEBRUARY 1, 2013. THE FIRST FOLLOW-UP MDR 2432235-2013-00046_S1 WAS FILED ON AUGUST 9, 2013. CORRECTION (8/13/13): THE MDRS FOR THIS EVENT WERE INCORRECTLY FILED WITH THE REGISTRATION NUMBER (B)(4). THE CORRECT REGISTRATION NUMBER FOR RIA FREE TESTOSTERONE KITS IS (B)(4).

N

Patient 1

THE INITIAL MDR 2432235-2013-00046 WAS FILED ON FEBRUARY 1, 2013. ADDITIONAL INFORMATION (7/17/13): SIEMENS TECHNICAL OPERATIONS CONFIRMED THAT INTERNAL TESTING OF RIA FREE TESTOSTERONE KIT LOTS 1458, 1462, AND 1463 HAD BEEN PERFORMED AND ALL THREE KITS WERE RELEASED WITHIN THE MANUFACTURER SPECIFICATIONS. SIEMENS GLOBAL PRODUCT SUPPORT HAS NOT RECEIVED COMPLAINTS FROM ANY OTHER CUSTOMERS ABOUT RIA FREE TESTOSTERONE KIT LOTS 1458, 1462, AND 1463. ADDITIONAL INFORMATION (8/9/13): DURING FOLLOW-UP WITH THE CUSTOMER, THE CUSTOMER STATED THAT THE PHYSICIAN(S) WHO HAD QUESTIONED THE LOW RESULTS HAVE NOT HAD ANY MORE QUESTIONS OR CONCERNS ABOUT RESULTS OBTAINED.