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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 Pain (1994); Skin Discoloration (2074); Swelling/ Edema (4577)
Event Date 02/08/2021
Event Type  Injury  
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 the skin irritation.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.
 
Event Description
It was reported while a patient had been wearing a pod for longer than 48 hours they experienced pain and swelling at the pod insertion site (arm).In addition the pod site was dark and discolored.The patient had gone to a scheduled visit to their endocrinologist and the doctor prescribed the patient cephalexin (250 mg x 2) to be taken for 5 days.
 
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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
jordan biswurm
100 nagog park
acton, MA 01720
9786007000
MDR Report Key11346595
MDR Text Key232516263
Report Number3004464228-2021-02533
Device Sequence Number1
Product Code LZG
UDI-Device Identifier20385082000020
UDI-Public(01)20385082000020(11)200924(17)220324(10)PS1K09242021
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 02/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date03/24/2022
Device Model Number18320
Device Catalogue NumberBLE-I1-529
Device Lot NumberPS1K09242021
Was Device Available for Evaluation? No
Date Manufacturer Received02/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/24/2020
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age59 YR
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