MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR ENLITE MMT-7008; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-7008

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Inflammation (2443)

Event Date 10/28/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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

Continuous glucose monitoring (cgm) is an established technology to control and regulate glucose levels for people with diabetes.These medical devices have to be applied to the user¿s skin to assess the interstitial glucose concentration continuously.The average wear time of cgm systems has been steadily increased by manufacturers over the last years.An increase in cgm wear time reduces the frequency of sensor changes and can lead to fewer sensor needle insertions through the skin as well as lower health care costs for cgm sensors.However, increased wear times are likely achieved by using stronger sticking adhesives, which may have a more pronounced effect on the skin than adhesives with less adherence time.Studies have already described that some of the substances contained in the adhesive parts and components of the cgm sensor itself, especially acrylates, are recognized to sensitize the skin.However, detailed information about the adhesive components used in medical systems is rare and frequently the adhesives of cgm systems consist of a mixture of different material components.Thus, without knowing the exact composition, for affected cgm user, it is hard to avoid systems containing the triggering factors.These factors may contribute to the increasing number of skin reactions, such as allergic reactions, itching, or rashes observed in patients using cgm.In 4 articles, 13 diagnoses of contact dermatitis were documented.In 9 cases of in total 71 subjects, the cgm system was used, 2 cases out of 24 subjects occurred due to an unknown system, and in articles using (in total 142 subjects) or the medtronic enlite sensor (in total 145 subjects) one contact dermatitis in each was described.

• Brand Name: SENSOR ENLITE MMT-7008
• Type of Device: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• 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 ; 8185464805
• MDR Report Key: 9380106
• MDR Text Key: 168430784
• Report Number: 2032227-2019-122783
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-7008
• Device Catalogue Number: MMT-7008
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2019
• 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): Other