MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD; BLOOD GLUCOSE MONITORING DEVICE

Device Problems Defective Device (2588); Application Program Problem (2880); Computer Operating System Problem (2898)

Patient Problems Hyperglycemia (1905); Vomiting (2144)

Event Date 01/24/2016

Event Type  malfunction  

Event Description

My daughter is a type 1 diabetic and uses the omnipod system.She constantly has defective pods.Recently, she was in the hospital and her endocrinologist had the in-house omnipod rep come to the hospital and put a pod on her.When she checked her sugar in order to eat, the system told her the pod wasn't working, so the rep brought another pod.This past weekend, she put 200 units in her pod, went to eat and her system told her she did not have enough insulin for her meal.She began throwing up.Her sugar was so high, it would not register on the meter, it just read "high." it continued to read "high" so she began giving herself injections with her novolog pen.She has a new pod but is continuing to have readings 240, 250.She celebrated her (b)(6) birthday today, so she's wanted me to put off calling the doctor because, more than likely, she'll end up back in the hospital.I've been reading reviews on the omnipod system and see that they have had recalls, warnings, lawsuits, etc.I'm not sure what to do at this point.I'm not sure what the return policy is.I still owe money on the system, but with the problems we continue to have and seems the problems are worsening, i'm strongly considering no longer using the system.I plan to discuss with the doctor in the morning and probably the company from whom we bought the omnipod system.

• Brand Name: OMNIPOD
• Type of Device: BLOOD GLUCOSE MONITORING DEVICE
• Manufacturer (Section D): INSULET CORPORATION
• MDR Report Key: 5821902
• MDR Text Key: 50420185
• Report Number: MW5063629
• Device Sequence Number: 1
• Product Code: LZG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 04/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Weight: 73