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 Hyperglycemia (1905); Pneumonia (2011); Renal Failure (2041); Coma (2417); Loss of consciousness (2418)

Event Date 09/08/2021

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 reported hospitalization and hyperglycemia.It was also reported that the cannula had dislodged from the infusion site.This condition could interrupt insulin delivery and contribute to hyperglycemia.No lot release records were reviewed, as the product lot number was not provided.

Event Description

It was reported by spouse that the patient had been hospitalized and admitted to the intensive care unit (icu) due to hyperglycemia.The patient's blood glucose levels rose to "beyond reading" (>250 mg/dl) while wearing the pod between 1 and 4 hours.Due to adhesive being loose and the cannula dislodging, the pod was removed prior to going to hospital and was discarded.Symptoms reported include pneumonia, loss of consciousness and kidney failure.The patient was being treated with antibiotics, intravenous fluids, fentanyl and a "white liquid to keep her asleep".The patient was currently in a diabetic coma in the icu at the time of reporting.

• 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: marisa peterson ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 12507144
• MDR Text Key: 272495220
• Report Number: 3004464228-2021-16681
• 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: K192659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/08/2021

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: 09/08/2021
• Initial Date FDA Received: 09/21/2021
• 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): Hospitalization
• Patient Age: 49 YR