MAUDE Adverse Event Report: UNOMEDICAL A/S QUICK-SET® PARADIGM®

Model Number MMT-397

Device Problem Leak/Splash (1354)

Patient Problem Coma (2417)

Event Date 12/19/2019

Event Type  Injury  

Manufacturer Narrative

The complaint has been reviewed based on the customer complaint description and evaluates that no further investigation can be performed before information about lot number and/or used samples are received for testing.

Event Description

Unomedical reference number: (b)(4).This event occured in (b)(6).A diabetic patient on pump therapy reported that the patient was hospitalized on (b)(6)2020 with high blood glucose and symptoms of nausea, vomiting, abdominal pain and breath difficulties.The patient experienced being in coma.Blood glucose at time of event was 1200 mg/dl.The patient was wearing pump at time of event.The infusion set was reported wet and leaking.No further information available.

• Brand Name: QUICK-SET® PARADIGM®
• Type of Device: QUICK-SET
• 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
• MDR Report Key: 9691708
• MDR Text Key: 182714972
• Report Number: 3003442380-2020-00001
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244006416
• UDI-Public: 05705244006416
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160648
• 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: 02/10/2020

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: MMT-397
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/14/2020
• Initial Date FDA Received: 02/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening