FDA.reportPublic FDA data

MAUDE MDR 4616031

MDR report key
4616031
Report number
2182595-2015-00001
Event key
0
Event type
3
Date received
2015-03-16
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
MARI MEYER
Address
1951 NORTHWESTERN AVE. PO BOX 285 STILLWATER MN 55082 US
Phone
651-651-6513
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1THE PRO-TRAC II TACROLIMUS ELISA KITENZYME IMMUNOASSAY, TACROLIMUSDIASORIN, INC.MLM32400/32400-CN131716/131717Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-03-160

Event Narratives#

D

Patient 1

THE PRO-TRAC II TACROLIMUS ELISA KIT IS FAILING MULTIPLE INTERNAL SPECIFICATIONS: ABSORBANCE OF THE CALIBRATOR ZERO (OD), CALIBRATOR 1 (OD) - CALIBRATOR 5 (OD), CALIBRATOR 1 (OD) - CALIBRATOR ZERO(OD). DIASORIN INC HAS CONFIRMED THAT THE FAILURE MANIFESTS AS A DECREASE IN THE TOTAL ASSAY SIGNAL RESULTING IN A SHIFT IN THE CALIBRATION CURVE. THIS SHIFT MAY CAUSE DISCORDANT ELEVATED TACROLIMUS RESULTS TO BE REPORTED ON A PATIENT'S SAMPLE. EVALUATION SUMMARY ATTACHED.

N

Patient 1

NO CUSTOMER REPORTS OF INJURY OR ILLNESS HAVE BEEN RECEIVED. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DIASORIN THAT THIS PRODUCT CAUSED OR CONTRIBUTED TO ANY ALLEGED INJURY OR ILLNESS. THIS REPORT IS BEING SUBMITTED IN COMPLIANCE WITH THE MDR REGULATIONS.