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Lot Number L41580
Event Date 11/21/2015
Event Type  Injury  
Event Description

Failures of insulet corporation's omnipod insulin pumps. Omnipod insulin pumps have two operating components: a small disposable pump, called "pod," worn on the body of a diabetic patient, and a close-range remote controller, called the pdm, used to control the pod, via a radio signal within a range of several feet. (b)(6), living in (b)(6), had three of his omnipod insulin pods fail consecutively on (b)(6) 2015 and (b)(6) 2015, while spending time with his father, (b)(6). All three failures were similar: unexplained rise in (b)(6) blood glucose, to very high levels, starting a couple of hours after a bolus, sometimes the correction dose, is administered using the pod. The changes of (b)(6) glucose levels are observed using his continuous glucose monitor (cgm) which is verified intermittently using (b)(6) blood glucose meter in the pdm. Shortly after (b)(6) has his pod replaced, his blood glucose decreases to normal levels. Very recently, an additional problem was manifested: unexpectedly low blood glucose only several hours after applying and activating a new pod. These problems were observed by (b)(6) father, (b)(6), who cared for (b)(6) during that time. (b)(6) observed similar problems with (b)(6) glucose control starting at least as early as (b)(6) 2015. But (b)(6) did not suspect failures of the pods until (b)(6) 2015 and, thus, has not documented those previous suspected failures. (b)(6) does not recall observing such problems during the summer of the year 2015. Observation is possible only every other weekend which (b)(6) spends with his father. (b)(6) mother, (b)(6), claims that there were no problems with the pods. But (b)(6) has told his father on (b)(6) 2015, that the school nurse and his class aide have remarked about increase number of occurrences of (b)(6) having high blood glucose and low blood glucose. (b)(6) has reported my observations, of problems with my son's glucose control, to insulet customer service on (b)(6) 2015 on the telephone and then very early in the morning on (b)(6) in writing, (b)(6). But insulet's almost disinterested response is a reason to doubt that they will diagnose the cause of these malfunctions. Their focus is "how soon would you like to receive replacement pots?" despite it being clear that replacement pods are a bad idea now. Reporting on telephone was very frustrating and finding a way to submit a written report to insulet via the internet has taken a little time, too. (b)(6) had to insist on reporting in writing to get help finding out how to use the submission form on their website. On (b)(6), insulet's customer-service representative has reiterated to (b)(6) that he report any future problems to insulet on telephone rather than in writing. The customer-service representative has refused to give to (b)(6) the full names of the managers who have told her to say it to (b)(6). Insulet is not interested in obtaining logs from (b)(6) continuous glucose monitor and from the omnipod pdm. Insulet's customer service refuse to put (b)(6) in contact with insulet's engineering team. Lot #'s and serial #'s of the 3 pods subject of this report: lot #l41580, sn #(b)(4); lot #l41580, sn #(b)(4); lot # l41580, sn #(b)(4), see detailed report, in a copy of (b)(6) message to lev's endocrinologist, starting at the 7th paragraph (number "1), at http://problemsindiabetescare. Blogspot. Com/2015/11/urgent-safety-problem-with-insulet. Html.

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Type of DeviceOMNIPOD
Manufacturer (Section D)
MDR Report Key5290573
Report NumberMW5058443
Device Sequence Number1
Product CodeLZG
Report Source Voluntary
Reporter Occupation OTHER
Report Date 12/08/2015
3 DeviceS WERE Involved in the Event: 1   2   3  
1 Patient Was Involved in the Event
Date FDA Received12/08/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Device EXPIRATION Date12/22/2015
Device LOT NumberL41580
Was Device Available For Evaluation? No Answer Provided
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

Date Received: 12/08/2015 Patient Sequence Number: 1