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 07/10/2015

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.We are unable to determine if any product condition could have contributed to the reported hospitalization for surgery and low bg's were noted.Lot release records were reviewed and the product lot met all acceptance criteria.The omnipod 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 that while she was in the hospital for hysterectomy her bg went to 36 mg/dl and was treated with glucose by iv.No further information has been received.

• 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 suit; billerica MA 01821
• Manufacturer Contact: david simard ; 600 technology park drive; suite 200; billerica, MA 01821 ; 9786007000
• MDR Report Key: 5018085
• MDR Text Key: 23563155
• Report Number: 3004464228-2015-00572
• 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
• Report Date: 07/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2016
• Device Model Number: 14000
• Device Catalogue Number: ZXP425
• Device Lot Number: L41719
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/21/2015
• Date Device Manufactured: 04/26/2015
• 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): Hospitalization
• Patient Age: 39 YR