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

Model Number 670

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

Patient Problem Insufficient Information (4580)

Event Date 11/08/2021

Event Type  malfunction  

Event Description

Patient called to report that he received an email on 11/8/2021 stating that his medtronic insulin pump was part of a recall.Patient stated the email said there was an issue with the clear retainer ring and that medtronic will be replacing his pump.Patient said he has not experienced any adverse events due to this product issue.Patient stated in his recall email it said to contact fda to file a report.

• Brand Name: MEDTRONIC 670 INSULIN PUMP
• Type of Device: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 12786951
• MDR Text Key: 280750657
• Report Number: MW5105225
• Device Sequence Number: 1
• Product Code: OYC
• 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: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 670
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Sex: Male