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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSULET OMNIPOD INSULIN PUMP

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INSULET OMNIPOD INSULIN PUMP Back to Search Results
Model Number OMNIPOD
Event Date 11/08/2014
Event Type  Injury  
Event Description

My (b)(6) son received the omnipod insulin pump manufactured by insulet recently. On every third day or last day of wear, the insulin pod seemingly failed because his glucose levels increased to abnormally high levels. We informed insulet corporation of the problem and the company sent us a new omnipod replacement pdm device. However, on the first day of using the replacement omnipod pdm device on (b)(6), my son's glucose rose to 240 mg/dl on the first day, after one meal. This glucose value is atypical for him. The pod did not give any warning alarm to notify us of any insulin delivery problems. The humalog insulin that was inside of the pod was fresh and expires in 2017. My son continues to receive lantus as his basal insulin and he did not miss any lantus doses. We do not use the insulin pump or pod for his basal insulin delivery but only for his mealtime boluses. After this high glucose value, we instead gave him a traditional shot of humalog 1 unit via a pen shot and his glucose came down to a normal level or 116 mg/dl after 20 minutes.

 
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Brand NameOMNIPOD
Type of DeviceINSULIN PUMP
Manufacturer (Section D)
INSULET
MDR Report Key4253540
Report NumberMW5039049
Device Sequence Number1
Product CodeLZG
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/08/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/08/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
Device EXPIRATION Date02/29/2016
Device MODEL NumberOMNIPOD
Device Catalogue NumberPOD-ZXP425
Device LOT NumberL41258

Patient TREATMENT DATA
Date Received: 11/08/2014 Patient Sequence Number: 1
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