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

Model Number 14500-5A

Device Problem Low Test Results (2458)

Patient Problem Hyperglycemia (1905)

Event Date 05/28/2015

Event Type  malfunction  

Event Description

The patient's mother reported that her daughter was having an attack, she was trying to hurt herself, she's going out of control and this is how she acts when her bg is high.She called 911 and upon the paramedics arrival and bg meter comparisons were performed.Her pdm read 160 mg/dl vs bg in the 500's mg/dl for the paramedic's meter.They gave her a manual injection of insulin (exact dosage was not provided) and stayed with her for an hour until she was stable.She confirmed that she was using the (uncleared) freestyle lite strips.

Manufacturer Narrative

The product was not returned for evaluation.We are unable to confirm the reported inaccurate low measurement or to determine if it could have contributed to the patient's paramedics visit.The patient was informed that freestyle lite test strips which are not cleared for use with the omnipod insulin management system integrated (freestyle) blood glucose meter.Qualification records were reviewed and the product lot met all acceptance criteria.

Manufacturer Narrative

Returned device was evaluated and performed within specifications.Reported malfunction was not confirmed.

• Brand Name: OMNIPOD INSULIN PUMP
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): INSULET CORPORATION; billerica MA
• Manufacturer Contact: david simard ; 600 technology park dr. ; suite 200; billerica, MA 01821 ; 9786007000
• MDR Report Key: 4874987
• MDR Text Key: 6041678
• Report Number: 3004464228-2015-00174
• Device Sequence Number: 1
• Product Code: LZG
• Combination Product (y/n): N
• PMA/PMN Number: K122953
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2015
• 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
• Device Lot Number: L60213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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): Other
• Patient Age: 31 MO