FDA.reportPublic FDA data

MAUDE MDR 5632949

MDR report key
5632949
Report number
2032282-2016-00002
Event key
0
Event type
3
Date of event
2016-02-17
Date received
2016-05-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
KIMBERLY CRANE
Address
ONE BAXTER WAY WESTLAKE VILLAGE CA 91362 US
Phone
805-805-8053
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ADVATE PK AND DOSE CALCULATORMEDICAL DEVICE SOFTWAREMYPKFITBAXTER HEALTHCARE - DEERFIELDPHYV 1.0MYPKFITR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-05-040

Event Narratives#

N

Patient 1

(B)(4). MYPKFIT SOFTWARE IS MANUFACTURED IN THE UNITED STATES, HOWEVER, HAS NOT RECEIVED REGULATORY APPROVAL IN THE UNITED STATES AND IS NOT CURRENTLY MARKETED OR RELEASED IN THE U.S. MYPKFIT VERSION 1.0 IS CURRENTLY RELEASED ONLY IN (B)(6) AND WILL NOT BE MADE AVAILABLE IN ANY OTHER GEOGRAPHY. BAXALTA MEDICAL ASSESSMENT: GLOBALLY, THERE ARE CURRENTLY 2 VERSIONS OF MYPKFIT THAT ARE IN USE. BOTH VERSIONS 1 .0 AND 1.1 ARE EXPECTED TO PROVIDE ACCURATE DOSING RECOMMENDATIONS FOR PATIENTS WITH SEVERE HEMOPHILIA A (FACTOR VIII 1% (OR IF REMAINING FACTOR VIII TREATMENT IMPACTS THE TROUGH PK LEVEL). VERSION 1.1 CORRECTS FOR THIS LOWER DOSING POTENTIAL FOR PATIENTS WITH FACTOR VIII >1% OR REMAINING FACTOR VIII TREATMENT THAT IS IMPACTING TROUGH PK LEVEL. BOTH VERSIONS 1.0 AND 1.1 OF MYPKFIT PROVIDE AN ERROR MESSAGING IF THE CALCULATION IS FOR A RECOMMENDED DOSE

D

Patient 1

DOCTOR FROM (B)(6) HAS FOUND THAT THE PK MEASUREMENT RESULTS IS DIFFERENT ON PRODUCTION AND DEMO ENVIRONMENT (SAME ENTRIES TO THE TOOL). NO ADVERSE EVENT REPORTED. BELOW ARE THE INPUTS USED BY THE CUSTOMER AND THE DIFFERENCES THEY OBSERVED IN THE DEMO (V1.0) AND PRODUCTION (V1.1) ENVIRONMENTS: (B)(4).