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

Device Problem Infusion or Flow Problem (2964)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

In accordance with 21 cfr 803.22 (b)(2), we are notifying you that on (b)(6) 2012, a customer's father contacted roche diagnostics and reported an incident of hospitalization that had occurred the previous night.The caller said customer was in the hospital because his minimed insulin pump had a restriction on the insulin flow.The minimed insulin pump mentioned in this event is not manufactured or imported by our firm.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: INSULIN PUMP
• Type of Device: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 17526732
• MDR Text Key: 321131328
• Report Number: MW5133670
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1