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

Model Number MMT-XXX

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 04/15/2016

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: 2032227-2017-00675.

Event Description

The customer called to report that the sensors would bother her approximately 2 to 4 days after insertion.Customer reported that sensors caused an infection at the site and the site would get a rash and puss would come out.The transmitter was also used along with the sensor.The customer's blood glucose reading was unknown.Customer stated she received treatment from her doctor for the site infection and high blood glucose.The customer was provided with antibiotics for the infection.Customer had moved the site over 7 times and the problem persisted with each site change.The product was not 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: 6765386
• MDR Text Key: 81778691
• Report Number: 2032227-2017-33962
• 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: 04/15/2016
• 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): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 175