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); Off-Label Use (1494); Unintended Movement (3026)

Patient Problem Insufficient Information (4580)

Event Date 02/07/2023

Event Type  Injury  

Event Description

It was reported the patient was hospitalized due to hypoparathyroidism while wearing the pod for between 5 and 24 hours.The patient used the pod off label to deliver calcium treatment to keep her calcium levels at optimal levels.The pod reportedly fell off the infusion site (arm), causing the cannula to dislodge.The patient's calcium levels decreased too low and the patient was hospitalized for two days.As treatment, the patient was placed on a calcium infusion.The patient does not suffer from diabetes and the pod was not used for diabetes treatment as it is intended.The patient's blood glucose levels were not affected due to this issue.

Manufacturer Narrative

The device has not been returned/received to date.If the device is received, a supplemental report will be submitted with the investigation results.We are unable to determine if any product condition or its off label use could have contributed to the reported medical intervention.Lot release records were reviewed and the product lot met all acceptance criteria.Specifically, a pod is paired to a pdm and put through simulated use testing including communicating with the pdm, deployment, delivering fluid, occlusion detection, and freedom from hazard alarms.Omnipod dash® insulin management system user guide model: pdm-int2-d001-mm pt-000002-gbr-eng-mm-aw rev.004 11/20 introduction/page xii to xiii.Warning: rapid-acting u-100 insulin: the omnipod dash® system is designed to use rapid-acting u-100 insulin.The following u-100 rapid-acting insulin analogues have been tested and found to be safe for use in the pod: novorapid® (insulin aspart), fiasp® (insulin aspart), humalog® (insulin lispro), admelog® (insulin lispro) and apidra® (insulin glulisine).Novorapid, fiasp, humalog and admelog are compatible with the omnipod dash® system for use up to 72 hours (3 days).Apidra is compatible with the omnipod dash® system for use up to 48 hours (2 days).Before using a different insulin with the omnipod dash® system, check the insulin medication label and consult your healthcare provider.Refer to the insulin labelling and follow your healthcare provider¿s directions for how often to replace the pod.Fiasp has a faster initial absorption than other rapid-acting u-100 insulins; always consult with your healthcare provider and refer to the insulin labelling prior to use.Warnings: if you are unable to use the omnipod dash® system according to instructions, you may be putting your health and safety at risk.Talk with your healthcare provider if you have questions or concerns about using the omnipod dash® system properly.

• 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: michael spears ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 16463516
• MDR Text Key: 310466732
• Report Number: 3004464228-2023-05901
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385082000020
• UDI-Public: (01)20385082000020(11)220513(17)231113(10)PD1K05132221
• 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: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/13/2023
• Device Model Number: 18320
• Device Catalogue Number: BLE-I1-529
• Device Lot Number: PD1K05132221
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 29 YR
• Patient Sex: Female