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 Problems Erythema (1840); Local Reaction (2035)

Event Date 12/07/2021

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.(b)(4).

Event Description

Colophonium is a natural product consisting of a complex mixture of more than 100 substances derived from various species of standing pine trees.It can be used in both unmodified and modified forms as a fast-acting adhesive for commercial, medical, and industrial products.Colophonium is a well-known sensitizer and its main allergens are 222 products of unmodified and modified colophonium and some of the new resin acids, synthesized during modification.Recently, colophonium has been increasingly associated with allergic contact dermatitis (acd) caused by medical devices used for the management of diabetes.We report a case of a (b)(6), non-atopic girl with recurrent flares of acd caused by colophonium.She had suffered from type 1 diabetes (t1d) since the age of (b)(6) years and had been treated with multiple daily injections up to the age of (b)(6).She was then changed to continuous subcutaneous insulin infusion therapy due to brittle glycemic control.At the same time, a continuous glucose monitoring (cgm) device (enlite sensor, minneapolis, minnesota) was introduced to intensify her glycemic level monitoring.After 2 years, she developed erythema, papules, and vesicles on her arms at the site of insertion of the cgm device, suggesting acd.She was then patch tested with specific allergens belonging to resin and acrylate classes (butyl acrylate 0.1%, butanediol 1¿3 methacrylate 2%, colophonium 20%, ethyl acrylate 0.1%, isobornyl acrylate 0.1%, methyl methacrylate 2%, para tertiary butylphenol formaldehyde resin 1%, phenol formaldehyde resin 5%, sesquiterpene 0.1%, toluenesulfonamide formaldehyde resin 10%, and urea formaldehyde resin 10%).Readings on d3 resulted in a strong positive reaction (++) to colophonium 20% pet.And a weak reaction (+) to butanediol 1¿3 methacrylate 2% pet.Treatment with methylprednisolone ointment and emollient was initiated and the dermatitis rapidly cleared within a few days.The presence of colophonium in the adhesive of the glucose sensor was confirmed by the manufacturer of the device.The patient was highly sensitized to colophonium, as demonstrated by her strongly positive patch test reactions, due to her prolonged use of a cgm device.

• 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
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325
• Manufacturer Contact: tricha miles ; 18000 devonshire st.; northridge, CA 91325 ; 7635140379
• MDR Report Key: 13118108
• MDR Text Key: 283298926
• Report Number: 2032227-2021-237047
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• 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: 12/07/2021
• 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