MAUDE Adverse Event Report: MEDTRONIC MINIMED MIO ADVANCE; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Use of Device Problem (1670); Inadequate Instructions for Non-Healthcare Professional (2956)

Patient Problem Insufficient Information (4580)

Event Date 07/16/2021

Event Type  malfunction  

Event Description

Marketing materials claim the mio advance can be inserted with one hand.Instructions and training videos clearly show 2 hands being needed.Links to instructions: https://www.Youtube.Com/watch?v=2for6savxrq and https://youtu.Be/dkj8usomgm8 links to marketing materials.Https://www.Youtube.Com/watch?v=7adzosbyj7i and https://www.Medtronicdiabetes.Com/products/infusion-sets please note the difference between the instructions which call out for the skin to be stretched until smooth before insertion (step 10a in the ifu) and the marketing materials that do not show this action.The need to stretch out the skin during insertion means that the insertion process requires 2 hands.It also means that possible insertion locations that are shown in the instructions and training materials are impossible as one cannot reach the back of their own arm with both hands.I conclude that medtronic diabetes is making claims of their product that may not be supported by their own instructions and possibly beyond what is supported in the unmedical 510(k) for this product: k173879.The one-handed use claim is not supported by the device description, substantial equivalence discussion, or ¿ comparison of characteristics found within the summary of k173879.While the predicate device can us used with one hand, this set clearly requires 2, per their instructions.Fda safety report id # (b)(4).

• Brand Name: MIO ADVANCE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 12203525
• MDR Text Key: 263112823
• Report Number: MW5102670
• Device Sequence Number: 1
• Product Code: FPA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 113