MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-04 for ADVATE PK AND DOSE CALCULATORMEDICAL DEVICE SOFTWARE V 1.0 MYPKFIT manufactured by Baxter Healthcare - Deerfield.
[45477732]
(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%). There is a potential for version 1. 0 to have a lower dose recommendation level for patients with 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 <10 iu/kg body weight; 10 iu/kg is within the recommended dosing range for (b)(6). Therefore while sub-optimal dosing may be recommended by version i. 0 for non-severe hemophilia a patients, it is unlikely that patients would be at risk of under-dosing per the (b)(6) prescribing information. If the dosing is sub-optimal, there remains a potential risk for bleeding events, which may be serious by their anatomic location and/or magnitude of bleeding. Globally, outside of (b)(6), the ccds recommends that for prophylaxis routine prophylaxis the usual doses are 20 to 40 iu/kg body weight at intervals of 2 to 3 days. Severe hemophilia: if the patient has severe hemophilia a, with factor viii levels
Patient Sequence No: 1, Text Type: N, H10
[45477733]
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).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032282-2016-00002 |
| MDR Report Key | 5632949 |
| Date Received | 2016-05-04 |
| Date of Report | 2016-02-17 |
| Date of Event | 2016-02-17 |
| Date Mfgr Received | 2016-02-17 |
| Date Added to Maude | 2016-05-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KIMBERLY CRANE |
| Manufacturer Street | ONE BAXTER WAY |
| Manufacturer City | WESTLAKE VILLAGE CA 91362 |
| Manufacturer Country | US |
| Manufacturer Postal | 91362 |
| Manufacturer Phone | 8053723182 |
| Manufacturer G1 | BAXTER HEALTHCARE - DEERFIELD |
| Manufacturer Street | 1627 LAKE COOK ROAD |
| Manufacturer City | DEERFIELD IL 60015 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60015 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ADVATE PK AND DOSE CALCULATORMEDICAL DEVICE SOFTWARE |
| Generic Name | MYPKFIT |
| Product Code | PHY |
| Date Received | 2016-05-04 |
| Model Number | V 1.0 |
| Catalog Number | MYPKFIT |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - DEERFIELD |
| Manufacturer Address | 1627 LAKE COOK ROAD DEERFIELD IL 60015 US 60015 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-04 |