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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD DASH; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
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INSULET CORPORATION OMNIPOD DASH; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER Back to Search Results
Device Problems Device Alarm System (1012); Patient Device Interaction Problem (4001)
Patient Problem Insufficient Information (4580)
Event Date 10/03/2021
Event Type  Injury  
Event Description
As a long term user of omnipod classic pods and pdms, i have repeatedly called to complain about the excessive alerts that go off and cannot be silenced.Although i understand that some people may need or want a super loud, obnoxious, aggressive repeated beeping noise to disturb their sleep, ruin funerals/business meetings/etc., wake up their sleeping children, i do not want loud noises to ever play from either device.I would love it if there was a silent vibrate only option.I do not ever want to be alerted with an extremely unpleasant repetitive sound.It is clear online that many users agree with me, and hate the insufferable noises that the system requires.It has come to the point where i am at risk of losing my job, and loved ones don't want me around because the infernal beeping does not stop.My children are losing sleep and not developing properly because of the infernal noises.That is not acceptable.I understand there are some stupid people out there that need or want the loud noises, but there are many others' lives and sanity are being destroyed by the sounds.After repeatedly contacting omnipod customer service to make complaints, they do not ever take my suggestion into consideration.I have gotten to the point that i will have to find another method of diabetes management because the beeping is ruining my life.Fda safety report id # (b)(4).
 
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Brand Name
OMNIPOD DASH
Type of Device
SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
Manufacturer (Section D)
INSULET CORPORATION
MDR Report Key12589959
MDR Text Key275523437
Report NumberMW5104446
Device Sequence Number2
Product Code NBW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/04/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/06/2021
Type of Device Usage N
Patient Sequence Number1
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