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

Model Number 14500-5A

Device Problem Insufficient Information (3190)

Patient Problems Headache (1880); Hyperglycemia (1905); Diabetic Ketoacidosis (2364); Reaction (2414)

Event Date 07/03/2020

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 diabetic ketoacidosis.No lot release records were reviewed, as the product lot number was not provided.For your reference, insulet modified our internal investigation finding codes effective 25 may 2020 as part of an effort to improve the classification of findings to improve the power of trending data and make the findings more intuitive.The new findings codes will use the system of finding category (e.G.Hardware component), followed by the affected component (e.G.Needle), followed by the condition (e.G.Bent).Therefore you may notice findings that appear to be new or different but in fact are just renamed for improved data value.Insulet would be happy to explain any mapping of the old to new finding codes if you have any questions.

Event Description

It was reported that the patient had been hospitalized with diabetic ketoacidosis (dka).The patient's blood glucose levels reached 800 mg/dl while wearing the pod between 4 and 24 hours; patient reported the cause of medical event was due to unspecified malfunction of the personal diabetes manager.Symptoms reported include hyperglycemia and headache; patient also had an allergic reaction to the insulin provided at the hospital.The patient was treated with intravenous fluids, an injection for blood thinner and benadryl for throat swelling due to allergic reaction.The patient spent 6 hours in the emergency room (er), prior to being admitted to a hospital room, where she spent a total of 24 hours prior to being released.

• 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: 10289248
• MDR Text Key: 199554528
• Report Number: 3004464228-2020-11402
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 10385081140003
• UDI-Public: (01)10385081140003(10)L45241
• 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: 07/06/2020

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 14500-5A
• Device Catalogue Number: UST400
• Device Lot Number: L45241
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/06/2020
• Initial Date FDA Received: 07/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 38 YR