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

Model Number 14810

Device Problems Failure To Adhere Or Bond (1031); Unintended Movement (3026)

Patient Problem Hyperglycemia (1905)

Event Date 06/03/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.The patient 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.Mylife omnipod insulin management system ¿ user guide model: ent450 14518-5c-aw rev e 03/16 using the pod 5 / page 42 warning: check often to make sure the pod and soft cannula are securely attached and in place.A loose or dislodged cannula may interrupt insulin delivery.Verify there is no wetness or scent of insulin, where as may indicate the cannula has dislodged.Checking your blood glucose 7 / page 96 warning: test results greater than 13.9 mmol/l mean high blood glucose (hyperglycemia).Warning: if you get results below 3.9 mmol/l or above 13.9 mmol/l, but do not have symptoms of hypoglycemia or hyperglycemia (see chapter 9, living with diabetes), repeat the test.If you have symptoms or continue to get results that fall below 3.9 mmol/l or above 13.9 mmol/l, follow the treatment advice of your healthcare provider.

Event Description

The patient reported her blood glucose reached greater than 600 mg/dl and upon inspection she noticed the adhesive pad was coming loose which caused the cannula to come out of the skin.The pod was worn between 4 and 24 hours on the abdomen.There was wetness and insulin noted at the site.Hyperglycemia treated by patient activating new pod.

Manufacturer Narrative

The returned product was evaluated and performed as designed.Adhesive properties prior to use could not be determined.No defect or deficiency that would result in the cannula to fail to insert correctly or the pump to fail to deliver insulin was found.Lot number changed from l43656 to l43653.Expiration date changed from 07/27/2019 to 07/26/2019.Correction :device mfg date changed from 01/28/2018to 01/27/2018.

• 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 Key: 7657885
• MDR Text Key: 112996786
• Report Number: 3004464228-2018-04059
• Device Sequence Number: 1
• Product Code: LZG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122953
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,foreign
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/26/2019
• Device Model Number: 14810
• Device Catalogue Number: ZXY425
• Device Lot Number: L43653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1