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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 Hyperglycemia (1905); Neuropathy (1983); Scar Tissue (2060); Skin Inflammation/ Irritation (4545)
Event Date 05/06/2022
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 and scarring.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
The patient reported blood glucose (bg) values that reached 306 mg/dl.The patient also mentioned that a pod that they were wearing, caused scabbing and then a small scar, after removal.The patient reported having neuropathy in their hands.The pod was worn between 4 and 24 hours on the abdomen.
 
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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 Key14338503
MDR Text Key291229716
Report Number3004464228-2022-07552
Device Sequence Number1
Product Code LZG
UDI-Device Identifier20385082000020
UDI-Public(01)20385082000020(11)210713(17)230113(10)PD1C07132141
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 05/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date01/13/2023
Device Model Number18320
Device Catalogue NumberBLE-I1-529
Device Lot NumberPD1C07132141
Was Device Available for Evaluation? No
Date Manufacturer Received05/06/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/13/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age58 YR
Patient SexFemale
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