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

Model Number 14000

Device Problems Bent (1059); Activation, Positioning or Separation Problem (2906)

Patient Problem Hyperglycemia (1905)

Event Date 06/09/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.We are unable to confirm the reported needle mechanism failure and bent cannula, 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: ust400 17845-5a-aw rev b 09/17 changing your pod chapter 3 / pages 33 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.Checking your blood glucose chapter 4 / page 36: warnings: test results below 70 mg/dl mean low blood glucose (hypoglycemia).Test results greater than 250 mg/dl mean high blood glucose (hyperglycemia).If you get results below 70 mg/dl or above 250 mg/dl, but do not have symptoms of hypoglycemia or hyperglycemia (see "living with diabetes" on page 115), repeat the test.If you have symptoms or continue to get results that fall below 70 mg/dl or above 250 mg/dl, follow the treatment advice of your healthcare provider.

Event Description

The patient reported that her blood glucose reached 440mg/dl while wearing the pod on her arm for between 36 and 48 hours.She stated she could not see/locate the pink slide on the pod, indicating the pod did not deploy properly, and that the cannula appeared bent when the pod was removed.Treatment included changing the pod.

Manufacturer Narrative

The returned device was evaluated and performed as designed.The reported needle mechanism failure was not confirmed.The pod was received with cannula fired and needle fully retracted.No bend or kink was observed in the cannula.No malfunction or other product condition that would have contributed to the reported hyperglycemia was found.

• 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: 7665449
• MDR Text Key: 113288018
• Report Number: 3004464228-2018-04158
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385081120002
• UDI-Public: (01)20385081120002(11)170527(17)181127(10)L43135
• 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
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 06/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/27/2018
• Device Model Number: 14000
• Device Catalogue Number: ZXP425
• Device Lot Number: L43135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2017
• 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: 31 YR