FDA.reportPublic FDA data

MAUDE MDR 3427065

MDR report key
3427065
Report number
1219913-2013-00252
Event key
0
Event type
3
Date of event
2013-09-13
Date received
2013-10-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MS. EIMAN SULIEMAN
Address
333 CONEY STREET E. WALPOLE MA 02032 US
Phone
508-508-5086
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ADVIA CENTAUR CP CORTISOL (COR) ASSAYCORTISOL IMMUNOASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.JFTN/A04610138261N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-10-240

Event Narratives#

D

Patient 1

A FALSE LOW ADVIA CENTAUR CP CORTISOL RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE RESULT WAS OBTAINED AFTER DEXAMETHASON ADMINISTRATION. REPEAT TESTING WAS PERFORMED ON THE PATIENT SAMPLE AND THE RESULTS WERE HIGH. IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CORTISOL RESULTS.

N

Patient 1

THE CAUSE FOR THE DISCORDANT CORTISOL RESULT IS UNKNOWN. THE QUALITY CONTROL AND THE CALIBRATION WERE ACCEPTABLE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.