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

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.

• 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 Key: 16733273
• MDR Text Key: 313225848
• Report Number: 3004464228-2023-09613
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385082000020
• UDI-Public: (01)20385082000020
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211575
• Number of Events Reported: 1
• 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 Number: 18320
• Device Catalogue Number: BLE-I1-529
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/13/2023
• Initial Date FDA Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male