MAUDE Adverse Event Report: UNOMEDICAL A/S COMFORT SHORT

Model Number	100-240-01
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Death (1802)
Date of Event	02/05/2018
Type of Reportable Event	Death
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: COMFORT SHORT
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• MDR Report Key: 7439149
• Report Number: 8021545-2018-00005
• Device Sequence Number: 1092874
• Product Code: FPA
• UDI-Device Identifier: 05705244008458
• UDI-Public: 05705244008458
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K162812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/19/2018
• Supplement Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 04/18/2018
• Supplement Report FDA Received Date: 05/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death