MAUDE Adverse Event Report: MEDTRONIC DIABETES MIO; INFUSION PUMP SET

Model Number MIO

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hypoglycemia (1912)

Event Date 09/10/2017

Event Type  Injury  

Event Description

After replacing medtronic mio mmt-921 lot 5157422 on a 670g in automode a low blood glucose was achieved.Could not bring child's glucose up and sustain it long term.Noticed recall of infusion sets on 09/11/2017.This lot was identified as affected.

• Brand Name: MIO
• Type of Device: INFUSION PUMP SET
• Manufacturer (Section D): MEDTRONIC DIABETES
• MDR Report Key: 6861535
• MDR Text Key: 86120253
• Report Number: MW5072119
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• 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: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MIO
• Device Catalogue Number: MMT-921
• Device Lot Number: 5157422
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/12/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 7 YR
• Patient Weight: 43