FDA.reportPublic FDA data

MAUDE MDR 8154532

MDR report key
8154532
Report number
1823260-2018-04808
Event key
0
Event type
3
Date of event
2018-11-06
Date received
2018-12-12
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
NA MICHAEL LESLIE
Address
9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US
Phone
317-317-3175
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ELECSYS CORTISOL IIFLUOROMETRIC, CORTISOLROCHE DIAGNOSTICSJFTNA07027150190336133R *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-12-120

Event Narratives#

N

Patient 1

THE EVENT OCCURRED IN: (B)(6).

D

Patient 1

THE CUSTOMER COMPLAINED OF A QUESTIONABLE ELECSYS CORTISOL II RESULT FOR 1 PATIENT SAMPLE TESTED ON A COBAS 8000 E 801 MODULE COMPARED TO THE RESULT FROM A SIEMENS CENTAUR SYSTEM. THE ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE COBAS E801 USED AT THE CUSTOMER'S SITE SERIAL NUMBER WAS (B)(4). THE COBAS E801 USED AT THE INVESTIGATION SITE SERIAL NUMBER WAS (B)(4). THE CORTISOL REAGENT USED ON THIS INSTRUMENT WAS LOT 336133 WITH AN EXPIRATION DATE 19-NOV-2019. THE INVESTIGATION IS CURRENTLY ONGOING.