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U.S. Department of Health and Human Services

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

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INSULET CORPORATION OMNIPOD BLOOD GLUCOSE MONITORING DEVICE Back to Search Results
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.

 
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Brand NameOMNIPOD
Type of DeviceBLOOD GLUCOSE MONITORING DEVICE
Manufacturer (Section D)
INSULET CORPORATION
MDR Report Key5821902
Report NumberMW5063629
Device Sequence Number1
Product CodeLZG
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
0 PatientS WERE Involved in the Event:
Date FDA Received04/12/2016
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
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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