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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSULET CORPORATION PODPAL; ADHESIVE

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INSULET CORPORATION PODPAL; ADHESIVE Back to Search Results
Model Number 18320
Device Problems Loss of or Failure to Bond (1068); Unintended Movement (3026)
Patient Problem Hyperglycemia (1905)
Event Date 01/03/2024
Event Type  malfunction  
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.No lot release records were reviewed, as the product lot number was not provided.
 
Event Description
It was reported the patient's blood glucose level rose to >250 mg/dl while wearing the pod for less than 1 hour.The pod reportedly fell off the infusion site (abdomen), causing the cannula to dislodge.
 
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Brand Name
PODPAL
Type of Device
ADHESIVE
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 Key18730723
MDR Text Key335702664
Report Number3004464228-2024-05909
Device Sequence Number1
Product Code KGX
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 02/19/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number18320
Device Catalogue NumberBLE-I1-529
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/27/2024
Initial Date FDA Received02/19/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age54 YR
Patient SexMale
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