MEDTRONIC 670G INSULIN PUMP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-14 for MEDTRONIC 670G INSULIN PUMP manufactured by Medtronic Minimed.

Event Text Entries

[180043832] I prepared to change my infusion set site for my minimed 670g pump. I used the silhouette infusion sets and the "sil-serter" - the inserter that accompanies those sets. After i loaded a new set into the inserter and went to remove the needle from the new cannula, i could not dislodge the needle from the cannula at the new site. The needle, from i understand, is used to insert the cannula under the skin and once removed allows for the insulin reservoir to be attached or removed based upon activity or preference etc. Because i was unable to remove the needle from the new site and cannula, i had to completely remove the new infusion set and discard it. This led to extreme discomfort and bleeding. I also am not sure why the needle would not dislodge from the new set / cannula area after insertion. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5093017
• MDR Report Key: 9720592
• Date Received: 2020-02-14
• Date of Report: 2020-02-12
• Date of Event: 2020-02-08
• Date Added to Maude: 2020-02-18
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: MEDTRONIC 670G INSULIN PUMP
• Generic Name: AUTOMATED INSULIN DOSING DEVICE SYSTEM
• Product Code: OZP
• Date Received: 2020-02-14
• Model Number: 670G
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDTRONIC MINIMED

Device Sequence Number: 2

• Brand Name: SIL-SERTER
• Generic Name: INTRODUCER, SYRINGE NEEDLE
• Product Code: KZH
• Date Received: 2020-02-14
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: MEDTRNIC MINIMED

Device Sequence Number: 3

• Brand Name: SILHOUETTE SET
• Generic Name: SET, ADMINISTRATION, INTRAVASCULAR
• Product Code: FPA
• Date Received: 2020-02-14
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: MEDTRONIC MINIMED

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2020-02-14