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

Model Number 14000

Device Problem Insufficient Information (3190)

Patient Problem Hypoglycemia (1912)

Event Date 07/23/2015

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation.We are unable to determine if any product malfunction or other product condition could have contributed to the reported hypoglycemia and emt visit.Lot release records were reviewed and the product lot met all acceptance criteria.The omnipod¿s user guide warns "test results below 70 mg/dl mean low blood glucose (hypoglycemia).If you get results below 70 mg/dl, but do not have symptoms of hypoglycemia, repeat the test.If you have symptoms or continue to get results that fall below 70 mg/dl, follow the treatment advice of your healthcare provider,¿ and it advises "hypoglycemia can occur even when a pod is working properly.Never ignore the signs of low blood glucose (no matter how mild).If left untreated, severe hypoglycemia can cause seizures or lead to unconsciousness.If you suspect that your blood glucose level is low, check your bg level to confirm.".

Event Description

The customer reported (b)(6) 2015 his blood glucose, carbohydrate intake and insulin history is as follows: (b)(6).

Manufacturer Narrative

The returned product was evaluated and performed as designed.No defect or deficiency that would result in the cannula failing to insert correctly or the pump failing to deliver insulin 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
• 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: 5022122
• MDR Text Key: 23736015
• Report Number: 3004464228-2015-00605
• 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: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2016
• Device Model Number: 14000
• Device Catalogue Number: ZXP425
• Device Lot Number: L41743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2015
• 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 Outcome(s): Other
• Patient Age: 71 YR