MAUDE Adverse Event Report: UNOMEDICAL A/S SILHOUETTE PARADIGM INFUSION SET

Model Number MMT-377

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

The claimed failure cannot be confirmed.No failure reported.If new information becomes available, the complaint will be re-opened and appropriate actions will be taken.

Event Description

(b)(4).A diabetic patient on pump therapy passed away.Date unknown.The incident was reported by a friend of patient when she called to ask if patient's infusion sets (lot number) were apart of the recall inquired what led up to the complaint.She was advised that the lot number was not a part of recall.She mentioned that she did not have the details surrounding the patient's death.No further information available.

• Brand Name: SILHOUETTE PARADIGM INFUSION SET
• Type of Device: SILHOUETTE PARADIGM
• 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 ; 0458167000
• MDR Report Key: 7230158
• MDR Text Key: 98641623
• Report Number: 8021545-2018-00003
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244009332
• UDI-Public: 05705244009332
• 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
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2020
• Device Model Number: MMT-377
• Device Lot Number: 5184757
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2015
• 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