FDA.reportPublic FDA data

MAUDE MDR 3734577

MDR report key
3734577
Report number
1415939-2014-00087
Event key
0
Event type
3
Date received
2014-04-08
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
NOEMI ROMERO-KONDOS, RN BSN
Address
100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 ABBOTT PARK IL 60064 US
Phone
847-847-8479
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ARCHITECT CYCLOSPORINECYCLOSPORINEABBOTT LABORATORIESMKW01L75-2533387M500Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-04-080

Event Narratives#

D

Patient 1

THE CUSTOMER OBSERVED A FALSELY ELEVATED CYCLOSPORINE RESULT FOR ONE PATIENT ON THE ARCHITECT I1000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED: INITIAL 1300 UG/L (SUSPECT FALSELY ELEVATED, QUESTIONED BY THE DOCTOR). 1:4 DILUTION AND OBTAINED

N

Patient 1

AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4). AN EVALUATION IS IN PROCESS.

N

Patient 1

FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF LABELING AND ACCURACY TESTING. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE PRODUCT WAS NOT AVAILABLE FOR RETURN. ACCURACY TESTING OF THE REAGENT LOT WITH TWO LEVELS OF AN INTERNAL PANEL (EACH LEVEL CONTAINS A KNOWN CONCENTRATION OF THE CYCLOSPORINE ANALYTE) MET ALL SPECIFICATIONS. COMPLAINT INFORMATION REASONABLY SUGGESTS THE ASSAY IS PERFORMING AS INTENDED, AND NO MALFUNCTION OF THE DEVICE OCCURRED. BASED ON THE AVAILABLE INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.