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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM; PUMP, INFUSION, INSULIN

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INSULET CORPORATION OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM; PUMP, INFUSION, INSULIN Back to Search Results
Model Number 18320
Device Problem Insufficient Information (3190)
Patient Problems Cellulitis (1768); Skin Inflammation/ Irritation (4545); Contact Dermatitis (4546)
Event Date 05/24/2022
Event Type  Injury  
Event Description
It was reported that a skin irritation causing red knots at 7 pod infusion sites.The patient is using pods for off label use as they are being filled with cortisol and not insulin.The patient had gone to urgent care where they were diagnosed with dermatitis.The patient was prescribed triamcinolone acetonide cream (1%) to be used 3 times daily.In addition the patient was advised to use hydrocortisone.The patient was at urgent care for 15 minutes.The patient had gone for a follow up with their doctor due to the pod infusion sites had larger knots.The patient was diagnosed with cellulitis.The patient was prescribed bactrim (800 mg) as well as oral tablets of bactrim (160 mg) to be taken once daily for 10 days.
 
Manufacturer Narrative
According to the complainant the device will not be returned for investigation.We are unable to determine if any product condition could have contributed to customer's infusion site infection.Lot release records were reviewed and the product lot met all acceptance criteria.The omnipod is iso10993 compliant, undergoing cytotoxicity, sensitization, genotoxicity, hemolysis, irritation or intracutaneous reactivity, systemic toxicity, and implantation effects testing.The omnipod is sterilized with 100% ethylene oxide gas with a sterility assurance level of 10-6  per iso11135  and eo residual levels in compliance with iso10993.Each lot  is confirmed to meet requirements for non-pyrogenicity per iso10993 and sterility per iso11135 prior to release.
 
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Brand Name
OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM
Type of Device
PUMP, INFUSION, INSULIN
Manufacturer (Section D)
INSULET CORPORATION
100 nagog park
acton MA 01720
Manufacturer (Section G)
INSULET CORPORATION
100 nagog park
acton MA 01720
Manufacturer Contact
michael spears
100 nagog park
acton, MA 01720
9786007000
MDR Report Key14687255
MDR Text Key294780845
Report Number3004464228-2022-09643
Device Sequence Number1
Product Code LZG
UDI-Device Identifier20385082000020
UDI-Public(01)20385082000020(11)210910(17)230310(10)PD1C09102141
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K192659
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 06/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date03/10/2023
Device Model Number18320
Device Catalogue NumberBLE-I1-529
Device Lot NumberPD1C09102141
Was Device Available for Evaluation? No
Date Manufacturer Received06/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/10/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age40 YR
Patient SexFemale
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