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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 Problems Loss of or Failure to Bond (1068); Unintended Movement (3026)
Patient Problems Pain (1994); Skin Infection (4544); Skin Inflammation/ Irritation (4545)
Event Date 04/09/2023
Event Type  Injury  
Event Description
It was reported the patient's blood glucose read "high" (>27.8 mmol/l,>500 mg/dl) while wearing the pod between 25 and 36 hours.The pod reportedly was coming loose from the infusion site (arm), causing the cannula to dislodge.The pod was removed and a correction was administered utilizing an insulin pen.The patient reported pain and irritation at the insertion site and visited the healthcare provider (hcp).The patient was diagnosed with a skin infection and was prescribed an ointment (ichtholan) and an antibiotic (clindamycin) for treatment.
 
Manufacturer Narrative
According to the complainant the device will not be returned for investigation.It was reported that the cannula had dislodged from the infusion site.This condition could interrupt insulin delivery and contribute to hyperglycemia.We are unable to determine if any product condition could have contributed to customer's infusion site infection.No lot release records were reviewed, as the product lot number was not provided.
 
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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
thom mcnamara
100 nagog park
acton, MA 01720
9786007000
MDR Report Key16733273
MDR Text Key313225848
Report Number3004464228-2023-09613
Device Sequence Number1
Product Code LZG
UDI-Device Identifier20385082000020
UDI-Public(01)20385082000020
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K211575
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 04/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number18320
Device Catalogue NumberBLE-I1-529
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/13/2023
Initial Date FDA Received04/13/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age36 YR
Patient SexMale
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