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

Model Number 14000

Device Problem Insufficient Information (3190)

Patient Problems Hypoglycemia (1912); Sepsis (2067); Loss of consciousness (2418)

Event Date 09/08/2020

Event Type  malfunction  

Manufacturer Narrative

According to the complainant the device is not being returned for investigation.We are unable to determine if any product condition could have contributed to the reported hospitalization.No lot release records were reviewed, as the product lot number was not provided.

Event Description

It was reported that the patient went to the hospital and was diagnosed with sepsis.While at the hospital, the patient suffered low blood glucose (bg) of unspecified values.For treatment, the patient was given some antibiotics for the sepsis, but no treatment for the blood glucose was disclosed.The patient lost consciousness, while at the hospital and can give very little details.The pod was worn on the arm and removed at the hospital and discarded.The patient was discharged after staying 6 days, between the 8th and 13th.

• Brand Name: OMNIPOD INSULIN PUMP
• 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: 10673779
• MDR Text Key: 211271319
• Report Number: 3004464228-2020-16148
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385081120002
• UDI-Public: (01)20385081120002
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122953
• 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: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 14000
• Device Catalogue Number: ZXP425
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 69 YR