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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD INSULIN PUMP; PUMP, INFUSION, INSULIN

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INSULET CORPORATION OMNIPOD INSULIN PUMP; PUMP, INFUSION, INSULIN Back to Search Results
Device Problems Break (1069); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem Hyperglycemia (1905)
Event Date 12/20/2019
Event Type  Injury  
Event Description
On the evening of thursday, (b)(6) 2019 my omnipod insulin pump stopped working.The next day ((b)(6)) i called omnipod to advise, and request a replacement pump.I was told a replacement pump would be sent out that day, and i would receive same the following day ((b)(6)).I did not receive the replacement pump that saturday (b)(6).The next day ((b)(6)), i called omnipod to inquire as to the status of the replacement pump.I was told the replacement was sent out via "ground" and i would receive it in 7-10 days.I told the rep this timeframe was unacceptable, and she assured me a second replacement pump would be sent out the next day ((b)(6)) to be delivered on (b)(6).This was not ideal, but i believed i had no other option.Meanwhile, my blood glucose was in the 300 range.I did not receive the second replacement pump that tuesday (b)(6).I called omnipod that day (b)(6) to inquire as to the tracking number of the second replacement pump, and was advised that no second replacement pump was sent, and the original replacement pump would be delivered (b)(6) (9 days ater my pump stopped working, and 8 days after omnipod was notified.) i was told my "only" other option was of them to send another replacement pump out on (b)(6) (2 days later), for delivery on (b)(6) (3 days later, 8 days after my pump stopped working, and 7 days after omnipod was notified).I demanded to speak with a supv.After a very long wait, the supv finally came on the line and reiterated that my "only" option was for another replacement to be sent out two days later, on (b)(6) for delivery on (b)(6).I told the supv i did not believe her, and that my next call would be to the fda.I also advised that i am a lawyer, and was considering filing a lawsuit against omnipod for the damage their errors did to my health.Only then did she mention that they "might" be able to get it delivered the next day / (b)(6), by using a different delivery service.She then told me that because i already told her that i didn't have a print-out of my original pump's settings, she could not send the pump using that service.I advised her that my settings are irrelevant to obtaining a replacement pump, that i knew what my settings should be, and that i could call my dr if had any issues.She continued to insist she couldn't do it, so i finally told her that i did have a print-out of the settings, in an effort to get her to send the pump.She then told me that she could not send the pump using that service because i already told her that i had a "back-up plan" for insulin therapy.I told her, from the beginning, that my only "back-up plan" consisted of using short-acting insulin to help offset the extremely high blood glucose levels.She insisted that access to insulin at all is considered a back-up plan, and since i told her that i had access to insulin, she could not send the pump using that service.Again, i finally told her that i had no access to insulin, in an effort to get her to send the pump.She put me on hold for a very long time, and did not come back on the line until i called omnipod from a different telephone to confirm that was not simply sitting on hold for no reason.She then told me it was too late for the delivery service to deliver next day / (b)(6), and that delivery would be (b)(6).I can't help but believe that had she initiated the delivery with this alternate delivery service at the beginning of my call, rather than nearly an hour later, i would have received the replacement pump a day earlier - (b)(6).The pump finally arrived on (b)(6) (7 days after my pump stopped working, 6 days after omnipod was notified, and 5 days after my initial replacement pump should have arrived - with my blood glucose consistently in the 300 range).This is unacceptable.Fda safety report id# (b)(4).
 
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Brand Name
OMNIPOD INSULIN PUMP
Type of Device
PUMP, INFUSION, INSULIN
Manufacturer (Section D)
INSULET CORPORATION
MDR Report Key9539115
MDR Text Key173648732
Report NumberMW5091963
Device Sequence Number1
Product Code LZG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age38 YR
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