MAUDE Adverse Event Report: MEDTRONIC MINIMED MEDTRONIC 670G INSULIN PUMP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Lot Number 1780KPK

Device Problems Nonstandard Device (1420); Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 05/10/2021

Event Type  malfunction  

Event Description

Patient called to report she received a recall letter via email on (b)(6) 2021.Patient stated the email said the ring that holds the insulin container into the pump needs to be replaced.Patient stated that hers is still functioning, however the manufacturer said they are still going to replace it and will get in touch with her when her pump should be sent in.

• Brand Name: MEDTRONIC 670G INSULIN PUMP
• Type of Device: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 12583885
• MDR Text Key: 275398693
• Report Number: MW5104431
• Device Sequence Number: 1
• Product Code: OYC
• 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: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 1780KPK
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR