MAUDE Adverse Event Report: UNOMEDICAL A/S INFUSION SET COMFORT

Model Number 100-006-03

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Death (1802)

Event Date 08/08/2015

Event Type  Death  

Manufacturer Narrative

To be provided when submitting the final report.Final report is expected submitted no later than 10/22/2015.

Event Description

A (b)(6) years old male diabetic patient being treated with insulin via a pump and an infusion set.On (b)(6) 2015 the patient's father finds his son diseased with pump alarming call service.Unomedical is investigating this case and trying to obtain further information.

Manufacturer Narrative

Clinical evaluation: the father of deceased patient called with question regarding return of pump.The father of patient described that patient was home alone when he passed away.The used infusion set was probably not returned for testing.The pump history: (b)(6) 2015 10:58 am occlusion 14500c0.(b)(6) 2015 5:31 pm occlusion 14500c4.(b)(6) 2015 empty cartridge 3:50 pm.The father indicated that there was an area of the old tubing that looked different and he felt may have been a blockage in the tubing.The returned tubing was visually inspected without any remarks as to any abnormal/unusual appearance.This may not be the tubing from the actual infusion set used at time of death.The black box shows that there were priming events after the occlusion but there is nothing which indicates whether the patient was attached/infusion set in body while priming.There is not enough available information to perform a clinical evaluation.If the patient did not change the set when given the alarms but continued to bolus then it is likely that patient infused to much insulin which caused the death of patient.Unclear what was tested.

Event Description

A (b)(6) years old male diabetic patient being treated with insulin via a pump and an comfort infusion set.On (b)(6) 2015 the patients father finds his son diseased with pump alarming call service.Unomedical and distributor company animas have investigated this case trying to as much information as possible.

• Brand Name: INFUSION SET COMFORT
• Type of Device: COMFORT
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, n/a DK-43 20; DA DK-4320
• Manufacturer (Section G): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, DK-43 20; DA DK-4320
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, DK-43-20 ; 548167000
• MDR Report Key: 5171795
• MDR Text Key: 161178137
• Report Number: 0008021545-2015-00001
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2019
• Device Model Number: 100-006-03
• Device Catalogue Number: N/A
• Device Lot Number: 5062814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/27/2015
• Initial Date FDA Received: 10/24/2015
• Supplement Dates Manufacturer Received: 08/27/2015
• Supplement Dates FDA Received: 10/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2014
• 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): Death
• Patient Age: 24 YR
• Patient Weight: 100