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

Model Number MMT-396

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Heart Failure (2206); Diabetic Ketoacidosis (2364)

Event Date 04/12/2018

Event Type  Death  

Manufacturer Narrative

The reference samples were visually inspected and tested for flow, leak and ventilation.All test results were within specifications.The batch record # 5179695 was verified and found it within specifications.The claimed failure cannot be confirmed.An investigation has been performed based on the customer complaint description and the reference samples from the same lot number.According to unomedical's traceability records, no relevant deviations were found.If new information becomes available, the complaint will be re-opened and appropriate actions will be taken.

Event Description

(b)(4).On (b)(6) 2018 a male diabetic patient on pump therapy changed his infusion set.Spouse indicated that he might not have completed the infusion set change correctly.Thinks he got distracted and did not realize he was not getting any insulin.On (b)(6) 2018 he experienced a diabetic ketoacidosis and was admitted to the (b)(6) medical center.The infusion set and pump was removed and patient was treated for the high blood glucose level of 1200 mg/dl.Until (b)(6) 2018.The hospital kept treating patient who was not able to get off the ventilator.On (b)(6) 2018 patient died of heart failure and natural passing after being removed from the ventilator.It is unknown if patient during the time of the hospitalization was treated for his diabetes via the pump or iv injections.No further information provided.

• Brand Name: QUICK-SET PARADIGM
• Type of Device: QUICK-SET PCC
• 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: 7539970
• MDR Text Key: 109101131
• Report Number: 3003442380-2018-00019
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244006775
• UDI-Public: 05705244006775
• Combination Product (y/n): N
• 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: 05/24/2018

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 Expiration Date: 04/01/2020
• Device Model Number: MMT-396
• Device Lot Number: 5179695
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/25/2018
• Initial Date FDA Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2017
• 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