MAUDE Adverse Event Report: MEDTRONIC MINIMED TRANSMITTER; SENSOR, GLUCOSE, INVASIVE

Model Number MMT-XXX

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Unspecified Infection (1930); Skin Irritation (2076); Swelling (2091)

Event Date 01/01/2015

Event Type  Injury  

Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.Reference manufacturer report number: 2032227-2015-40032.

Event Description

The customer reported via phone call that she experienced skin irritation and infection from the infusion sets and sensors and had to be hospitalized at the end of (b)(6) with diabetic ketoacidosis.The customer stated that the first time was around (b)(6) 2015 and it got worse on (b)(6).The customer stated she experienced high blood glucose and the site showed signs of infection; her skin color was white and greenish and it had swelling.Infusion set area was at the arm and sensor at the abdomen.The customer stated she could only use the infusion set for one and a half days and the sensor for 3 or 4 days before the skin becomes irritated.The transmitter was also used in conjunction with the sensor.She stopped using the insulin pump about a week prior to the hospitalization due to the skin infection.Customer was advised to contact her doctor for options.The product will not be returned for analysis.

• Brand Name: TRANSMITTER
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire st.; northridge, CA 91325-1219
• MDR Report Key: 6765621
• MDR Text Key: 81780187
• Report Number: 2032227-2017-34040
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-XXX
• Device Catalogue Number: MMT-XXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/15/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 22 YR
• Patient Weight: 144