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

Model Number 14000

Device Problem Retraction Problem (1536)

Patient Problem Hyperglycemia (1905)

Event Date 07/20/2015

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.We are unable to confirm the reported needle mechanism issue (fail to retracted) or to determine if it could have contributed to the reported hyperglycemia, or to determine the root cause.Lot release records were reviewed and the product lot met all acceptance criteria.The omnipod¿s user guide warns to "check the infusion site after insertion to ensure that the cannula was properly inserted.The pdm will automatically remind you to check your blood glucose 1.5 hours after each pod change.If the cannula is not properly inserted, hyperglycemia may result," and "test results greater than 250 mg/dl mean high blood glucose (hyperglycemia).If you get results above 250 mg/dl, but do not have symptoms of hyperglycemia, repeat the test.If you have symptoms or continue to get results above 250 mg/dl, follow the treatment advice of your healthcare provider.".

Event Description

The customer reported her blood glucose reached 404 mg/dl and that the needle did not retract back into the pod.She stated that the site was painful, swelling, and red and there was bleeding noted at the insertion site.The pod was worn between 36 and 48 hours.

Manufacturer Narrative

The returned product was evaluated and the failure of the needle mechanism was confirmed.Mechanism rails-wings did not capture slide insert/did not go through was determined to be the root cause.

• Brand Name: OMNIPOD INSULIN PUMP
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): INSULET CORPORATION; 600 technology park drive; suite 200; billerica MA
• Manufacturer (Section G): INSULET CORPORATION; 600 technology park drive suit; billerica MA
• Manufacturer Contact: david simard ; 600 technology park drive; suite 200; billerica, MA ; 9786007000
• MDR Report Key: 5015966
• MDR Text Key: 23530729
• Report Number: 3004464228-2015-00564
• 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
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 07/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2016
• Device Model Number: 14000
• Device Catalogue Number: ZXP425
• Device Lot Number: L41666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2015
• 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: 13 YR