MAUDE Adverse Event Report: BAXTER HEALTHCARE - DEERFIELD ADVATE PK AND DOSE CALCULATORMEDICAL DEVICE SOFTWARE; MYPKFIT

Model Number V 1.0

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/17/2016

Event Type  malfunction  

Manufacturer Narrative

(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 i%, there is the potential that version 1.0 will calculate a lower recommended dose than version 1.1.Therefore, there is a finite risk that the lower recommended dose, if selected by the physician, may be associated with bleeding event(s), representing sub-optimal dosing.Changing from version 1.0 to version 1.1.: if the patient moves from version 1.0 to version 1.1, no such concern about dosing is likely to exist.It is unlikely that use of version 1.1 would be associated with sub-optimal dosing for non-severe hemophilia a patients, due to the correction calculations as discussed above.There is not a perceived risk increase for patients with severe hemophilia a.Mypkfit is intended to provide dosing recommendations, not to replace physician judgement in establishing the optimal dose for advate.If a physician were to use the device without adding their clinical assessment of the patient's needs for dose adjustment, there is an inherent risk of sub-optimal dosing, or under-doing.This risk would apply to both versions 1.0 and 1.1 of mypkflt.Conclusion: there exists a small but finite potential risk for sub-optimal dosing of patients with non-severe hemophilia a, associated with the use of mypkfit version 1.0 in (b)(6) (but not a corresponding risk for mypkfit version 1.1 ).Patients who are sub-optimally dosed for hemophilia a may be at risk for a serious bleeding event.Mitigations that have been established and are currently in place in (b)(6) to manage these potential risks include: there is an error message if calculated dose <10 iu/kg.The lower bounds of advate dose recommendations in the (b)(6) prescribing information is 10iu/kg, which aligns with the mypkfit error message.Mypkfit is intended to provide dosing recommendations, not to replace physician judgement in establishing the optimal dose for advate.The device is accompanied by instructions that the physician use their clinical assessment of the patient's needs for advate dosing decisions.We believe that these mitigations will minimize the risks of sub-optimal dosing.Investigation found the cause of the dosing difference is due to the fact that the (b)(6) clinic received mypkfit version 1.0 in the demo environment and then mypkfit version 1.1 in the production environment.The investigation determined that even though mypkfit v1.0 was planned to be deployed into the clinics in (b)(6) (because the device is currently under review by a regulatory authority in (b)(6)), the it team inadvertently released the upgraded mypkfit v1.1.As a result, (b)(4) clinics in (b)(6) received v1.1 versus the intended v1.0.Algorithm improvements were implemented in the mypkfit v1.1 software device, which impacts the dose calculation for patients with moderate to mild hemophilia (natural baseline of 2% or greater).There is no impact or differences in dose calculations between versions 1.0 or 1.1 with regard to severe hemophilia a patients, who are the main population for the intended use.Both versions 1.0 and 1.1 provide dose calculations that are within the labeling requirements of the (b)(6) pi/spc.Additionally, in reviewing the customer inputs and differences and considering in (b)(6), nominal potency assignments per vial, in either case the patient would likely be prescribed 750iu vial for dosing.Also, considering the dose from a bodyweight standpoint, the minor difference in dose per iu/kg is within the range of variability of the fviii potency assignment assay, and within the acceptable range of potency of the 750iu vial.The case was reported to the authorities in (b)(6).Post market escalation (b)(4) and capa pr# (b)(4) were initiated for this complaint issue.

Event Description

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).

• Brand Name: ADVATE PK AND DOSE CALCULATORMEDICAL DEVICE SOFTWARE
• Type of Device: MYPKFIT
• Manufacturer (Section D): BAXTER HEALTHCARE - DEERFIELD; 1627 lake cook road; deerfield IL 60015
• Manufacturer (Section G): BAXTER HEALTHCARE - DEERFIELD; 1627 lake cook road; deerfield IL 60015
• Manufacturer Contact: kimberly crane ; one baxter way; westlake village, CA 91362 ; 8053723182
• MDR Report Key: 5632949
• MDR Text Key: 45477732
• Report Number: 2032282-2016-00002
• Device Sequence Number: 1
• Product Code: PHY
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: V 1.0
• Device Catalogue Number: MYPKFIT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2016
• Initial Date FDA Received: 05/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1