MAUDE Adverse Event Report: MEDTRONIC MINIMED MINIMED INSULIN PUMP; AUTOMATED INSULIN DOSING , THRESHOLD SUSPEND

Device Problems Moisture Damage (1405); Component Missing (2306)

Patient Problem Hyperglycemia (1905)

Event Date 06/29/2019

Event Type  Injury  

Event Description

Hyperglycemia/hyperglycemia; using my medtronic insulin pump while on vacation.Accidentally wore pump while swimming in lake for less than one minute.Should have been no problem but discovered that reservoir seal ring was missing, allowing water in and damaging the pump.Although i have back-up insulin pens i had not used this method of control for several years, and had to guess at dosages.This occurred in remote area without phone or medical services.I reported this to medtronic as soon as i was able and they replaced the pump.Fda safety report id# (b)(4).

• Brand Name: MINIMED INSULIN PUMP
• Type of Device: AUTOMATED INSULIN DOSING , THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 12638720
• MDR Text Key: 276881497
• Report Number: MW5104640
• Device Sequence Number: 1
• Product Code: OZO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/12/2021

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 70