MAUDE Adverse Event Report: UNOMEDICAL A/S COMFORT SHORT

Model Number 100-240-01

Device Problem No Apparent Adverse Event (3189)

Patient Problem Death (1802)

Event Date 02/05/2018

Event Type  Death  

Manufacturer Narrative

On 18-apr-2018: used infusion set received for investigation on 17-apr-2018.These will be tested and follow up mdr report with test result will be submitted thereafter.

Event Description

Unomedical reference number: (b)(4).Reporter (hcp) stated police were called for a while being check.Police found patient deceased on his bed and he was deceased for about 1-2 days.Reporter stated the male diabetic patient was wearing the animas pump at the time of death around his waist.Reporter stated patient was brought to the medical examiner on (b)(6) 2018.Reporter stated the autopsy was done the (b)(6) 2018.Police reported that it was hot in the room.Blood glucose level unknown at time of event.Reporter felt death occurred due to use of the product.No malfunction has been reported.No further information available.

Manufacturer Narrative

On 16-may-2018: a visual inspection and a test for flow and leak were performed on the returned used device (1 set).Flow and leak test results were within specifications.On 18-apr-2018: used infusion set received for investigation on 17-apr-2018.These will be tested and follow up mdr report with test result will be submitted thereafter.

Event Description

(b)(4).Reporter (hcp) stated police were called for a while being check.Police found patient deceased on his bed and he was deceased for about 1-2 days.Reporter stated the male diabetic patient was wearing the animas pump at the time of death around his waist.Reporter stated patient was brought to the medical examiner on (b)(6) 2018.Reporter stated the autopsy was done (b)(6) 2018.Police reported that it was hot in the room.Blood glucose level unknown at time of event.Reporter felt death occurred due to use of the product.No malfunction has been reported.No further information available.

• Brand Name: COMFORT SHORT
• Type of Device: COMFORT SHORT
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer (Section G): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320 ; 558167000
• MDR Report Key: 7439149
• MDR Text Key: 105750231
• Report Number: 8021545-2018-00005
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244008458
• UDI-Public: 05705244008458
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162812
• 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: 05/16/2018

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 Model Number: 100-240-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/19/2018
• Initial Date FDA Received: 04/18/2018
• Supplement Dates Manufacturer Received: 03/19/2018
• Supplement Dates FDA Received: 05/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death