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

Model Number 14500-5A

Device Problem Unable to Obtain Readings (1516)

Patient Problems Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908)

Event Date 09/26/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.We are unable to determine if any product condition could have contributed to the reported hospitalization and hyperglycemia.No lot release records were reviewed, as the product lot number was not provided.Omnipod insulin management system ¿ user guide, model: ust400, 17845-5a-aw rev b 09/17.Checking your blood glucose chapter 4 / page 36: you should perform a control solution test when: you suspect that the built-in bg meter or test strips are not working properly.You think your bg readings are not accurate or are not consistent with how you feel.You drop or damage your pdm or expose it to liquids.Your healthcare provider advises you to do so.When you perform a control solution test, if the reading is within the control solution acceptable range, the built-in bg meter is working properly.With the built-in bg meter, checking your blood glucose requires a very small sample size, 0.3 microliters of blood.Checking your blood glucose chapter 4 / page 43: warning: "low" or "high" blood glucose readings can indicate a potentially serious condition requiring immediate medical attention.If left untreated, these situations can quickly lead to diabetic ketoacidosis (dka), shock, coma, or death.Consult your healthcare provider for how to treat high and low blood glucose levels.Living with diabetes chapter 11 / page 116: warning: keep an emergency kit with you at all times to quickly respond to any diabetes emergency.Prepare an emergency kit to keep with you at all time.The kit should include: several new, sealed pods, extra new pdm batteries (at least two aaa alkaline; do not use rechargeable batteries), a vial of rapid-acting u-100 insulin (see the introduction for insulins approved for use in the omnipod® system), syringes or pens for injecting insulin, blood glucose test strips, additional blood glucose meter, ketone test strips, lancing device and lancets, glucose tablets or another fast-acting source of carbohydrate, alcohol prep swabs, instructions from your healthcare provider about how much insulin to inject if delivery from the pod is interrupted, a signed letter from your healthcare provider explaining you need to carry insulin supplies and omnipod® system equipment, phone numbers for your healthcare provider and/or physician in case of an emergency, glucagon kit and written instructions for giving an injection if you are unconscious (see "avoid lows, highs, and dka" on page 119).Living with diabetes chapter 11 / page 119: avoid lows, highs, and dka: you can avoid most risks related to using the omnipod® system by practicing proper techniques and by acting promptly at the first sign of hypoglycemia, hyperglycemia, or diabetic ketoacidosis.The easiest and most reliable way to avoid these conditions is to check your blood glucose often.

Event Description

It was reported that the patient was in the icu (intensive care unit) because of blood glucose values reaching over 600 mg/dl and her blood pressure was 200+/100+.The patient also had a stroke.She is currently using syringes.The sister stated that the pdm (personal diabetes manager) would not register whenever she does a finger stick.The patient had stopped wearing the pod after the issue with the pdm meter had occurred and it is unclear when she stopped wearing pods and using the system.

• 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: 9234204
• MDR Text Key: 163743917
• Report Number: 3004464228-2019-10695
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 10385081140003
• UDI-Public: (01)10385081140003
• 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: 10/10/2019

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: 14500-5A
• Device Catalogue Number: UST400
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/10/2019
• Initial Date FDA Received: 10/24/2019
• 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: 61 YR