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

Model Number 14500-5A

Device Problem Unable to Obtain Readings (1516)

Patient Problem Hyperglycemia (1905)

Event Date 05/07/2019

Event Type  malfunction  

Manufacturer Narrative

The pdm was found to have a nonfunctioning bg meter board, resulting in a meter error 4.The pdm would not give bg readings upon strip insertions or sst test.Replacing the bg board resolved this issue.Lot release records were reviewed and the product lot met all acceptance criteria.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's blood glucose (bg) levels reached 432 mg/dl.The pdm (personal diabetes manager) was displaying meter error 4.

• 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: 9146179
• MDR Text Key: 190773629
• Report Number: 3004464228-2019-09575
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 10385081140003
• UDI-Public: (01)10385081140003(11)170811(10)L60719
• 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: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 14500-5A
• Device Catalogue Number: UST400
• Device Lot Number: L60719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Date Manufacturer Received: 09/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2017
• 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 Age: 7 YR