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

Model Number 14500-5A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Renal Failure (2041)

Event Date 03/31/2016

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 renal failure.Lot release records were reviewed and the product lot met all acceptance criteria.The omnipod user guide warns, "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 that fall above 250 mg/dl, follow the treatment advice of your healthcare provider.".

Event Description

Customer's mother reported recent changes in basal rate and her blood glucose level was not going down.Pdm appeared to be working incorrectly.Daughter was hospitalized with kidney failure and was having a shunt placed for dialysis.

• 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: 5614256
• MDR Text Key: 43845211
• Report Number: 3004464228-2016-01266
• 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: Patient
• Type of Report: Initial
• Report Date: 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 14500-5A
• Device Catalogue Number: ZXP425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/31/2016
• 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): Required Intervention
• Patient Age: 38 YR