MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR ENLITE; OZO

Model Number MMT-7008B

Device Problem Insufficient Information (3190)

Patient Problems Hyperglycemia (1905); Unspecified Infection (1930); Swelling (2091); Reaction (2414)

Event Date 07/31/2015

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.

Event Description

The customer reported via phone call that she experienced skin infection at the sensor insertion site.Customer stated that the site showed signs of infection; skin was swollen, red and warm to touch.Customer stated she had the infection in the abdomen and it lasted 30 days.The customer stated that if she leaves on the sensor too long, she gets an allergic reaction from the tape.Blood glucose value is unknown.She follows the proper insertion process.She was advised to contact the doctor for antibiotic options.

• Brand Name: SENSOR ENLITE
• Type of Device: OZO
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire street; northridge CA 91325
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire street; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764805
• MDR Report Key: 5090057
• MDR Text Key: 26228500
• Report Number: 2032227-2015-46450
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (y/n): N
• PMA/PMN Number: 120010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Report Date: 08/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-7008B
• Device Catalogue Number: MMT-7008B
• Device Lot Number: HG0KN0NH13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Weight: 62