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

Model Number 19191

Device Problem Positioning Failure (1158)

Patient Problem Hyperglycemia (1905)

Event Date 11/11/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.We are unable to confirm the reported needle mechanism failure or to determine its root cause.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.Using the pod 3/ page 32-33.Check the infusion site: following insertion of the cannula, check the infusion site: look through the viewing window to check that the cannula is inserted into the skin.The cannula is tinted light blue.Check for pink coloring in the area on the top of the pod shown in the figure.This is an additional check that the cannula was extended.Check for wetness or the scent of insulin at the insertion site.The presence of either may indicate that the cannula has dislodged.Warning: check the infusion site after insertion to ensure that the cannula was properly inserted.If the cannula is not properly inserted, hyperglycemia may result.

Event Description

It was reported that the cannula did not deploy; indicating a needle mechanism failure.The patient's blood glucose (bg) levels were 20 mmol/l (360 mg/dl) at the time.

• Brand Name: OMNIPOD 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: jordan biswurm ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 9535665
• MDR Text Key: 195016831
• Report Number: 3004464228-2019-14069
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385081120033
• UDI-Public: (01)20385081120033(11)190109(17)200709(10)L44494
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162296
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• 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: 07/09/2020
• Device Model Number: 19191
• Device Catalogue Number: ZXP425
• Device Lot Number: L44494
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2019
• 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
• Patient Age: 42 YR