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U.S. Department of Health and Human Services

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

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MEDTRONIC MINIMED SENSOR ENLITE MMT-7008 ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-7008
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Skin Irritation (2076); Skin Inflammation (2443)
Event Date 02/28/2020
Event Type  malfunction  
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
Multidisciplinary collaboration between several european dermatology departments has identified isobornyl acrylate (iboa; cas 5888-33-5), once deemed a low-risk sensitizer, as a major culprit contact allergen in glucose sensors and insulin pumps, medical devices used by diabetes patients worldwide. Isobornyl acrylate, a photopolymerizable acrylate monomer, is available as a liquid substance. It is used in coatings, sealants, glues, adhesives, paints, and inks and, according to some sources, also as a plasticizer in various plastic materials. From 2014 onward, several cases of allergic contact dermatitis (acd) related to the use of newly launched glucose monitoring devices (e. G. , enlite; medtronic, fridley, mn; ; and ) were observed throughout (b)(6). Overall, vigilance is required as some alternatives may contain potentially the same or cross-reactive acrylate sensitizers. For example, many patients, who react to the iboa-containing device, have also shown reactions to enlite sensors, raising the question whether the latter might also contain iboa. Recently, it was confirmed that iboa is a contact allergen in the enlite glucose sensor and likely also in the infusion set paradigm minimed quick-set. Isobornyl acrylate has been quite well characterized in terms of patch test modalities, concomitant reactions, and main allergen sources, but its precise cross reactivity profile as well as further allergen sources remains to be determined.
 
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Brand NameSENSOR ENLITE MMT-7008
Type of DeviceARTIFICIAL 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 Key9866498
MDR Text Key184505075
Report Number2032227-2020-102001
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Type of Report Initial
Report Date 03/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-7008
Device Catalogue NumberMMT-7008
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/28/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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