• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSULET OMNIPOD

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

INSULET OMNIPOD Back to Search Results
Lot Number VARIOUS
Event Date 07/02/2014
Event Type  Injury  
Event Description

Medical device safety issues - insulet omnipod insulin pump from (b)(6) (anonymity preferred with the company at this time please, if possible. I am willing to answer any questions. ) weekdays: (b)(6). I am significantly concerned about the safety of the insulet company's omnipod insulin pump for managing blood sugars and insulin delivery for people with type 1 diabetes. I know that many people use this system without issues or with limited issues and i've heard of many other people who have had similar problems. (some of my communications have taken place with other families with diabetes as well as using the diabetes online community. ) i would like to report the continuous problems and safety concerns that my (b)(6) year old child has had with this system. My child has used the "new version" of this system since (b)(6) 2013. I'm going to number my points and include "subject" topics on each to hopefully make the information flow easily. Device- the system consists of a "pdm'' (personal diabetes manager, which also functions as the blood glucose meter) and maintains all settings for the insulin delivery including bolusing and basal rates. Excerpt from their website on how it's supposed to work: (b)(4) "the pod holds and delivers the insulin. The pdm (personal diabetes manager) wirelessly programs your personalized insulin delivery, calculates suggested doses and insulin on board, and has a convenient, built-in freestyle blood glucose meter. " pod failures -back in (b)(6) 2014, a few months after we first received the system, there was a week where there were three (3) pod failures. Each time a pod fails its stops delivering insulin and stops communicating with the pdm. Over the next couple of months, there were just a couple of random pod issues as well as several pods falling off (e. G. Due to swimming. ) several weeks went by with minimal pod issues. Dead battery - pod failure - (b)(6) 2014 - today was another example of a pod failure. The pdm did not provide a battery warning but the device just died due to battery life. When we immediately added new batteries, the time and date were re-entered, then the system says the pod must be de-activated. When i called the helpline, they said the pod would continue to deliver the basal rate but they recommend the pod be deactivated. No other functions on the device (such as the blood sugar testing) would function at all - another safety issue, they also note any boluses and corrections would have to be manually calculated for the next six hours because of the pod failure. This is a huge safety issue because there is now no record of recent past boluses based on what they're saying. Also, the pod was just applied yesterday so with pods costing (b)(4)/day), basically two days (or $(b)(4)) were lost plus the expense of the lost insulin. For comparative purposes, if the battery on the medtronic pump dies, it has memory and retains all previous information including bolus history. The worst part of it, is the literal trauma to the child who has to have a new pod removed (as noted, it was only one day old and it is a huge challenge to remove the pod due to the strong tape (even using various chemicals such as unisolve to remove. ) there is always skin damage after the pod is removed. Then applying a new pod has it's own challenges and pain for the child so having to do it even more frequently than the expected every three days is ridiculous. No child should have to endure this! pod alarm - when a pod fails the child no longer receives insulin. The device may or may not alarm. The alarm is a vicious screech that cannot consistently be turned off using the pdm, especially if a new pod has already been activated just fall off. If a new one is activated without deactivating the old one (e. G. When one pod falls off), it will continuously alarm. Thus the pod has no connection with the pdm knowing which pod is active at the time. Cannot press a button to acknowledge the alarm. ) one would think that each pod device would have a unique (e. G. You identifier and this data would be retained in the pdm when that pod is activated. But apparently this is not how it's designed. Instead you must take a needle or end of a paperclip and insert it into some unmarked and difficult to find spot on the back of the pod and insert it into the pod to silence the alarm. If this doesn't work, and often it doesn't, people have recommended placing the pod in the freezer to silence it, or use a hammer to destroy the pod so it would stop alarming. (remember this device is being used by young children. ) pdm errors, pod failures and pins - in the course of three (3) days over this past (b)(6) weekend, we had six (6) different pod failures and a new thing - "pdm errors". When the first "pdm error" message occurred, i called insulet and their rep took the reference number and told me i had to remove the back battery door of the pdm (not the pod this time), then place a pin or needle or end of a paperclip into a tiny hole on the back of the pdm to "reset" the pdm machine. When this is done, it completely loses the time and date info and then cannot track past insulin on board, nor can it calculate a bolus for at least four hours. Because of this loss of communication, the system automatically deactivates the pod only to have to be replaced again. This process of sticking needles, pins or paper clips into tiny obscure holes on the pod or pdm device is ridiculous and completely unsafe, especially if a child is expected to safely use this device. (we were traveling staying in a hotel room at the time and didn't have a paperclip or pin to use every time. ) this also leads me to question the safety because it seems like the pdm has no memory of the "messages" or signals it's sending to the pod and how much insulin the pod has delivered. It just loses communication with the pod that is on the child's body. So we replaced the pod again and again and restarted the pdm several times. No pod-pdm communication after speaking with other people using the system (at the children with diabetes conference including reps from the insulet company), they noted that the pdm is supposed to be able to work within 5 feet of the pod (on the body); however, this one barely worked when it was within even 5 inches of the pod. After the fourth or fifth pod failure/pdm error and innumerable hours on the phone with omnipod customer service, i requested that they replace the entire pdm. The customer service rep, (b)(4), quite adamantly refused to do this because she said the pod was allegedly still delivering basal insulin (by this time i have no faith whatsoever that my child is getting insulin. ) i explained the part about the pdm not communicating unless it is directly next to the pod (instead of the five foot range) then finally with frustration, she said she would send a replacement pdm by next tuesday for that issue (but not for the pdm errors. ) i also asked that they replace the entire batch of pods (as these were all from one batch. ) she said i would need management, approval for that and i would have to call back the following week. Note: even if it was delivering basal insulin, the pod was not able to deliver insulin boluses which keep a child alive when they eat any food with carbohydrates. Expense as mentioned, each pod failure and pdm error results in loss of at least the $(b)(4) pod (which only lasts for three days) as well as all of the insulin in the pod (a minimum of (b)(4) units each time. ) with all of the pod failures and errors. I have lost at least entire bottle of novolog insulin which is also very expensive. They have replaced a couple of the pods but not all that have failed. Customer service: i have had to spend countless hours of my valuable time dealing with the omnipod customer service reps who generally seem to have no idea what any of the data means and very limited knowledge of the product. When i ask them what the various reference numbers mean (that appear in the pdm when a pod fails), they just say, "we don't know, they don't tell us. Our engineers use that information to make the product better. " if the codes define a list of things that are happening with the device, why would they not have an explanation list of the various reference codes? that could serve as "teaching tool for patients so if they do consistently encounter a particular reference code, perhaps that data could be used for education, as well as improving the product when trends are identified. New pdm­ - more pod failures. We did receive the new pdm, got the settings set up late last night, then applied a new pod to my child. With the first bolus, the pod failed again in the middle of the bolus! i called insulet this morning and asked to speak with a manager. I left a message. I did hear back from someone this afternoon who seems to be a management person and she seemed concerned and wanted to help. She said she would send some replacement pods to try. (however, we will not be able to do this until my child returns from diabetes camp. ) model#: not available at this moment.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameOMNIPOD
Type of DeviceOMNIPOD
Manufacturer (Section D)
INSULET
MDR Report Key4055921
Report NumberMW5038000
Device Sequence Number1
Product CodeLZG
Report Source Voluntary
Reporter Occupation Patient FAMILY MEMBER OR FRIEND
Type of Report Initial
Report Date 08/07/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/08/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Service Personnel
Device EXPIRATION Date07/02/2014
Device LOT NumberVARIOUS

-
-