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

Model Number 19191

Device Problem Material Twisted/Bent (2981)

Patient Problem Hyperglycemia (1905)

Event Date 12/11/2019

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: ent450.17845-5c-aw rev a 10/17.Checking your blood glucose 4 / page 36.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 "living with diabetes" on page 117), 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

It was reported the pod's cannula was bent.The patient's blood glucose (bg) rose to 18 mmol/l (324 mg/dl).In order to treat the high bg, the pod was changed and administered a manual injection of insulin.The pod was worn on the patient's arm for between 4 and 24 hours.

Manufacturer Narrative

The device was received and evaluated.The received device had the cannula assembly deployed.No bends or kinks were observed in the soft cannula.Fluid was able to flow through the fluid path with no signs of struggle.No other defects or deficiencies were found that would result in a failure of the device to deliver insulin.

• Brand Name: OMNIPOD INSULIN MANAGEMENT SYSTEM
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): INSULET CORPORATION; 100 nagog park; acton MA 01720
• MDR Report Key: 9535681
• MDR Text Key: 195015451
• Report Number: 3004464228-2019-14066
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385081120033
• UDI-Public: (01)20385081120033(11)190716(17)210116(10)L44984
• Combination Product (y/n): N
• PMA/PMN Number: K162296
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/16/2021
• Device Model Number: 19191
• Device Catalogue Number: ZXP425
• Device Lot Number: L44984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Date Manufacturer Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 37 YR