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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
Model Number 19191
Device Problem Insufficient Information (3190)
Patient Problems Hyperglycemia (1905); Vomiting (2144); Malaise (2359); Diabetic Ketoacidosis (2364)
Event Date 04/03/2023
Event Type  Injury  
Manufacturer Narrative
According to the complainant the device will not be returned for investigation.We are unable to determine if any product condition could have contributed to the reported hospitalization and diabetic ketoacidosis.No lot release records were reviewed, as the product lot number was not provided.High blood glucose is a common symptom for people with diabetes (glucose monitoring data from people with diabetes indicate that on average, they can experience blood glucose levels above 250 mg/dl for 14-25% of the time[1][2][3].), and it would be challenging to speculate on a cause for the complaints without receiving the devices back for an engineering investigation.[1] beck rw, bergenstal rm, cheng p, kollman c, carlson al, johnson ml, rodbard d.The relationships between time in range, hyperglycemia metrics, and hba1c.J diabetes sci technol 2019;13:614-626 [1] welsh jb, derdzinski m, parker as, puhr s, jimenez a, walker t.Real-time sharing and following of continuous glucose monitoring data in youth.Diabetes ther 2019;10:751-755 [1] puhr s, derdzinski m, welsh jb, parker as, walker t, price da.Real-world hypoglycemia avoidance with a continuous glucose monitoring system's predictive low glucose alert.Diabetes technol ther 2019;21:155-158.
 
Event Description
It was reported that the patient had been hospitalized with diabetic ketoacidosis (dka).The patient's blood glucose levels reached 650 mg/dl while wearing the pod between 4 and 24 hours on the leg.Symptoms reported include vomiting and getting sick.The patient was treated with intravenous therapy of fluids and insulin as well has being connected to a heart monitor.The patient was prescribed lantus (5u) and humalog icf: (1u) for 100 mg/dl over 150 mg/dl and icr: (1u) for every 30 grams to 33 grams of carbs at meals/corrections.The patient was released the following day.The pod was removed and discarded at the hospital.
 
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Brand Name
OMNIPOD INSULIN PUMP
Type of Device
PUMP, INFUSION, INSULIN
Manufacturer (Section D)
INSULET CORPORATION
100 nagog park
acton MA 01720
Manufacturer (Section G)
INSULET CORPORATION
100 nagog park
acton MA 01720
Manufacturer Contact
thom mcnamara
100 nagog park
acton, MA 01720
9786007000
MDR Report Key16766356
MDR Text Key313558803
Report Number3004464228-2023-09992
Device Sequence Number1
Product Code LZG
UDI-Device Identifier20385081120033
UDI-Public(01)20385081120033(11)220518(17)231118(10)L72403
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K211575
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 04/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date11/18/2023
Device Model Number19191
Device Catalogue NumberZXP425
Device Lot NumberL72403
Was Device Available for Evaluation? No
Date Manufacturer Received04/15/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/18/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age3 YR
Patient SexFemale
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