FDA.reportPublic FDA data

MAUDE MDR 3147253

MDR report key
3147253
Report number
1219913-2013-00129
Event key
0
Event type
3
Date of event
2012-11-01
Date received
2013-06-05
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
MS. EIMAN SULIEMAN
Address
333 CONEY STREET EAST 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 IMMUNOASSAYCORTISOL ASSAYSIEMENS HEALTHCARE DIAGNOSTICS, INC.JFTN/A04610049254-257N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-06-050

Event Narratives#

D

Patient 1

THE CUSTOMER REPORTED THAT THEY DID NOT RECEIVE AN ADVIA CENTAUR CP CORTISOL URGENT FIELD SAFETY NOTICE (B)(4) THAT WAS DISTRIBUTED TO CUSTOMERS IN MARCH 2012. THE CUSTOMER HAD RECEIVED A NEW REAGENT LOT OF CORTISOL WITH A NOTE CARD THAT REFERRED TO THE URGENT FIELD SAFETY NOTICE AND AFFECTED REAGENT LOTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES.

N

Patient 1

URGENT FIELD SAFETY NOTICE (B)(4) WAS PROVIDED TO THE CUSTOMER. THE CUSTOMER HAS CONFIGURED THE CALIBRATION INTERVAL TO EVERY 24 HOURS FOR DAILY CALIBRATION.