MAUDE Adverse Event Report: MEDTRONIC MINIMED MEDTRONIC MINIMED 670G INSULIN PUMP ; AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL

Model Number	670G
Health Effect - Clinical Codes	Hypoglycemia (1912); Loss of consciousness (2418)
Date of Event	01/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
I was on a business trip to (b)(6).I was staying in a hotel with an employee in another room.When i didn't show up for breakfast and then a following meeting the employee became concerned and eventually called police when i wouldn't answer my phone.The police ended up kicking my door in when they noticed from a crack in the curtains that i was laying in bed unconscious.The paramedics came and injected me with glucagon and i was revived.One of the paramedics told me that i had rolled over on my pump and had accidentally let all of the insulin out of my pump.I told him that was impossible and he said he sees it all the time.I said no i just filled up the reservoir a day ago because i didn't want to be dealing with that while traveling.He picked up the pump and showed it to me and the reservoir was out of insulin.I had been totally racking my brain as to how that could happen till i saw on the news that my medtronic minimed pump was on a list of pump being recalled.The recall stated that it was because of a defective o ring that could become damaged.I have the minimed 670g after i saw the recall on the tv, i called the company and they confirmed that my pump was included in the recall.I don't know why the company never sent me a letter or anything about this recall.I had to learn about it from watching the evening news.This company knows my phone number and address because they call constantly and send letters constantly reminding me that i owe them money but they never contacted me to tell me my pump could be a problem.I had to contact them.Now they are saying that they are going to send me a new pump.But guess what? it's the same pump with the same defective o ring.I'm not gonna wear this pump again and risk what happened to me.I'm pretty sure that paramedic that told me that he is constantly treating people who have accidentally rolled over on their pumps and released all of the insulin at once is actually treating people who are wearing this pump.I truly believe that the o ring itself is faulty.I have examined my pump and my o ring is loose but it's not cracked or damaged or missing.I think that the o ring itself is defective.I don't understand why y'all are letting them get off the hook so easily.If something is defective and you order a recall why are you allowing the company to replace something defective with the exact same defective product? fda safety report id# (b)(4).

• Brand Name: MEDTRONIC MINIMED 670G INSULIN PUMP
• Common Device Name: AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 9744552
• Report Number: MW5093199
• Device Sequence Number: 2650257
• Product Code: OZP
• UDI-Device Identifier: 00643169946057
• UDI-Public: (01)00643169946057(17)180412(12)
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 02/19/2020

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
• Operator of Device: No Information
• Device Expiration Date: 04/04/2018
• Device Model Number: 670G
• Device Catalogue Number: 670G
• Device Lot Number: MMT-1760KPK
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 56 YR
• Patient Weight: 57