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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 14000
Device Problem Bent (1059)
Patient Problems Hyperglycemia (1905); Pain (1994)
Event Date 06/09/2018
Event Type  malfunction  
Manufacturer Narrative
The device was not returned for evaluation.We are unable to confirm the bent cannula or to determine if it could have contributed to the reported hyperglycemia.Lot release records were reviewed and the product lot met all acceptance criteria.Omnipod insulin management system ¿ user guide model: ust400 17845-5a-aw rev b 09/17 checking your blood glucose chapter 4 / page 36 warnings: test results below 70 mg/dl mean low blood glucose (hypoglycemia).Test results greater than 250 mg/dl mean high blood glucose (hyperglycemia).If you get results below 70 mg/dl or above 250 mg/dl, but do not have symptoms of hypoglycemia or hyperglycemia (see "living with diabetes" on page 115), repeat the test.If you have symptoms or continue to get results that fall below 70 mg/dl or above 250 mg/dl, follow the treatment advice of your healthcare provider.
 
Event Description
It was reported that a patient's blood glucose levels reached 350 mg/dl while wearing the pod between 4 and 24 hours.When removed from the infusion site (abdomen), the pod's cannula was found bent.As treatment, a manual injection of insulin (3u) was delivered and a new pod was applied.It should be known that, during insertion, patient experienced pain.
 
Manufacturer Narrative
The device was returned with damage to the exterior and interior of the device.The soft cannula was returned bent into the cannula window.When the device was opened to perform the investigation, the ratchet gear could not be turned because one of the hook talons was bent into the ratchet gear.The batteries in the device were returned depleted.The pcb (printed circuit board) was removed from the device and connected to an external battery in an attempt to download the data from the device.No damage was found on the pcb, but the data could not be downloaded from the device after being connected to the external battery.Corrosion was noticed on the bottom battery.There also appeared to be fluid marks on the mechanism rails.Without further information, it cannot be determined how or when the damages to the device occurred.
 
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Brand Name
OMNIPOD INSULIN PUMP
Type of Device
PUMP, INFUSION, INSULIN
Manufacturer (Section D)
INSULET CORPORATION
600 technology park drive
suite 200
billerica MA 01821
Manufacturer (Section G)
INSULET CORPORATION
600 technology park drive
suite 200
billerica MA 01821
Manufacturer Contact
derek sammarco
600 technology park drive
suite 200
billerica, MA 01821
9786007000
MDR Report Key7665447
MDR Text Key113288151
Report Number3004464228-2018-04157
Device Sequence Number1
Product Code LZG
UDI-Device Identifier20385081120002
UDI-Public(01)20385081120002(11)171013(17)190413(10)L43400
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122953
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 06/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date04/13/2019
Device Model Number14000
Device Catalogue NumberZXP425
Device Lot NumberL43400
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/18/2018
Is the Reporter a Health Professional? No
Date Manufacturer Received08/09/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/13/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age9 YR
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