MAUDE Adverse Event Report: MEDTRONIC MINIMED INSULIN PUMP 630 ; AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND

Model Number MMT-17154K

Device Problems Break (1069); Nonstandard Device (1420); Unintended Collision (1429); Component Missing (2306)

Patient Problem Hyperglycemia (1905)

Event Date 12/05/2018

Event Type  malfunction  

Event Description

About a year and a half ago, i noticed that the clear ring around the reservoir on my medtronic model 630 insulin pump was missing.About 9 months later i dropped my pump and the black part around the same area broke off.On (b)(6) 2020 i learned that my pump was on your list of recalled medical devices.I called medtronic and they said my pump was not one such pump.However, they switched me to another dept and they quickly said they were sending a different pump to me along with a cover.This was sent overnight.My concern is that my a1c's have been 9.9 and 9.7 for a long period of time.What if this was in direct relation to the missing ring malfunction? i don't know what else to do but report my situation.Fda safety report id# (b)(4).

• Brand Name: INSULIN PUMP 630
• Type of Device: AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 9734031
• MDR Text Key: 180795252
• Report Number: MW5093152
• Device Sequence Number: 1
• Product Code: OZO
• 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: 02/17/2020

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: Lay User/Patient
• Device Model Number: MMT-17154K
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/19/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 109