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

Model Number 18320

Device Problem Insufficient Information (3190)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Loss of consciousness (2418)

Event Date 08/12/2020

Event Type  Death  

Manufacturer Narrative

According to the complainant the device will not be returned for investigation.We are unable to confirm the bent cannula or to determine if it could have contributed to the reported death.No lot release records were reviewed, as the product lot number was not provided.

Event Description

It was reported while a patient was wearing a pod they experienced shortness of breath and collapsed.Per the patients wife the patient had changed the pod on sunday and believes it was not put on correctly.The following day the patient was not feeling well and became week on tuesday.The patients wife states that she believes her husband was giving himself shots of insulin along with wearing the pod and he could have overdosed on insulin.While in the ambulance the patient received shot treatments.The patient passed away at the hospital.The patients cause of death has been listed by the coroner as cardiac arrest.

• 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 Key: 10482897
• MDR Text Key: 205303362
• Report Number: 3004464228-2020-13962
• 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: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 18320
• Device Catalogue Number: BLE-I1-529
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 75 YR