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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM; PUMP, INFUSION, INSULIN

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INSULET CORPORATION OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM; PUMP, INFUSION, INSULIN Back to Search Results
Model Number 18325
Device Problems Material Separation (1562); Unintended Movement (3026)
Patient Problem Hyperglycemia (1905)
Event Date 03/03/2022
Event Type  malfunction  
Event Description
It was reported the patient's blood glucose level (bg) rose to over 400 mg/dl while wearing the pod between 4 and 24 hours on the back.The pod reportedly was tearing away from the adhesive backing, causing the cannula to dislodge.As treatment patient was able to activate a new pod.
 
Manufacturer Narrative
According to the complainant the device will not be returned for investigation.It was reported that the cannula had dislodged from the infusion site.This condition could interrupt insulin delivery and contribute to hyperglycemia.Lot release records were reviewed and the product lot met all acceptance criteria.Specifically, a pod is paired to a pdm and put through simulated use testing including communicating with the pdm, deployment, delivering fluid, occlusion detection, and freedom from hazard alarms.
 
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Brand Name
OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM
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
michael spears
100 nagog park
acton, MA 01720
9786007000
MDR Report Key13722596
MDR Text Key286999253
Report Number3004464228-2022-04123
Device Sequence Number1
Product Code LZG
UDI-Device Identifier20385082000051
UDI-Public(01)20385082000051(11)210801(17)230201(10)PD1K08012121
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K192659
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 03/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date02/01/2023
Device Model Number18325
Device Catalogue NumberBLE-P1-525
Device Lot NumberPD1K08012121
Was Device Available for Evaluation? No
Date Manufacturer Received03/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age40 YR
Patient SexFemale
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