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

Model Number 14500-5A

Device Problem High Test Results (2457)

Patient Problem Hypoglycemia (1912)

Event Date 05/27/2016

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation.We are unable to confirm the reported inaccurate high bg measurement or to determine if it could have contributed to the patient's hospitalization.No product lot number was reported therefore no lot release records were reviewed.The omnipod user guide warns "if you are experiencing symptoms that are not consistent with your blood glucose reading and you have followed all instructions described in this user guide, call your healthcare provider immediately," and advises "you should perform a control solution test when you suspect that your meter or test strips are not working properly, when you think your test results are not accurate, or if your test results are not consistent with how you feel.".

Event Description

The patient's father reported his daughter's blood glucose history is as follows: time: 5:05 am, bg (mg/dl): 95.He then noticed a pod alarm.10 minutes later 11.She had a diabetic seizure while she was sleeping so he called for the paramedics.Upon their arrival her bg was reading at 11 mg/dl (with the emt's meter) and the pdm was reading at 95 and 94 mg/dl.They used something to help bring up her bg levels.Dad stated that he was not sure what the paramedics gave his daughter.She was taken to the hospital where they monitored her bg levels overnight.

• 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: 5749303
• MDR Text Key: 48188212
• Report Number: 3004464228-2016-01768
• 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: 05/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 05/27/2016
• Is the Device Single Use?: No
• 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: 4 YR