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 Itching Sensation (1943); Skin Irritation (2076); 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

Previous studies have shown that 43% to 90% of the participating children experienced dermatological complications when using continuous subcutaneous insulin infusion (csii) attached to the body [(with or without continuous glucose monitoring (cgm)] and that these types of complications tend to present in younger children.These dermatological complications include scars, nodules, and eczema (erythema, scaling, papules, and sometimes blisters) due to irritative or allergic contact dermatitis under the adhesives of sensors and pump sets and lipohypertrophy/-atrophy due to insulin infusion.The purpose of this cross-sectional study was to follow up on an initial study.For both studies, informed consent was obtained from participants¿ parents and from adolescents aged 15 years or older.The study was approved by the danish data protection agency and the research ethics committee.The follow-up questionnaire was sent to all patients four months after the initial study.Both of the questionnaires were sent to either patients or their parents with an online link and were completed at home.Patients answered the questionnaires approximately five months after the initial study.(mean: 5.09 months; 95% confidence interval [ci]:4.89-5.29).The questionnaire concerning dermatological complications due to csii and/or cgm was the same as that used in the initial study.New questions were also included regarding differences in treatment since patients had answered the first questionnaire, why changes were made, and whether the patients¿ dermatological complications had changed.Descriptive statistics were used to present age, sex, bmi, hba1c, duration of t1d, and csii and cgm treatments.Paired t-tests were used to compare dermatological complications reported in the initial and follow-up questionnaires.Independent sample t-tests were used to analyze differences in discomfort scores.Normality was assessed by visual inspection of histograms.Different dermatological complications were separated into groups for further analyses.The main groups were itching, specific current dermatological complications (eczema, wounds, and scars), and all currently visible dermatological complications including lipoatrophy, lipohypertrophy, changes in pigmentation, red/blue dot (small hematomas), and other types.The patients were separated into commonly used pump-duration categories: zero to one year, one to four years, four to six years, and over six years.In total, 136 patients were currently using csii and 93 patients were using cgm (two patients used cgm only).For five months since the initial trial, itching was the most frequent complication and was reported by 78.7% of csii users and 60.2% of cgm users.Other frequent complaints during this period were dry wounds (csii: 37.5% and cgm: 26.9%) and eczema (csii: 30.9% and cgm: 40.9%).Patients who were treated with csii and/or cgm during both trials were compared.There were no significant differences between the two time periods of answering the questionnaires (p >.05) for neither csii nor cgm.The researchers investigated whether the same patients were experiencing any dermatological complications to either csii or cgm in both the initial study and the follow-up.Follow up showed that 88 patients (64%) out of 138 were currently experiencing dermatological complications and 71 (81%) of those also had complications during the initial study.For symptoms of itching, results showed that 114 patients (82%) were currently experiencing itching and 89 (78%) of these 114 patients also had itching during the initial study.These results showed that if patients experienced itching or dermatological complications initially, the complications were likely to persist (p <.0001 for both).When analyzing cgm types, patients were either using enlite, , or . was excluded from the analysis due to the lack of power with only six patients using .Among 94 patients who were currently using cgm, 75% of the patients using enlite were experiencing itching in response to cgm treatment vs 41% of the patients on .In total, 58% of the patients on enlite had the current dermatological complications against 21% using .No significance in age, sex, bmi, z-score bmi, hba1c levels, or diabetes duration was found (p >.05).The duration of cgm treatment was found to be associated with the risk of itching (or: 1.75; p <.05), although the duration of cgm treatment depends on cgm type (p <.05).Simple logistic regression analysis showed that patients using enlite compared to experienced more dermatological complications in connection with both all current skin problems and specific current skin problems (or: 5.4; p <.001 and or: 6.1; p <.001, respectively).When using multivariate logistic regression to disregard the impact of cgm duration, association was still present (or: 5.1; p <.05 and or: 5.4; p <.05).No association between cgm type and itching was found after multivariate analysis (p >.05).After five months, results showed similar prevalence of dermatological complications when patients with t1d use modern technology for insulin delivering and glucose measuring.This demonstrated an ongoing issue in the same population.The results showed that 81% of the affected patients in the initial study also had dermatological complications at follow-up.

• 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: 9380089
• MDR Text Key: 168664631
• Report Number: 2032227-2019-122782
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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