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

Model Number MMT-397

Device Problem Connection Problem (2900)

Patient Problems Death (1802); Diabetic Ketoacidosis (2364)

Event Date 04/23/2018

Event Type  Death  

Manufacturer Narrative

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

Unomedical reference number (b)(4).On (b)(6) 2018 a male diabetic patient on pump therapy passed away due to diabetic ketoacidosis and coma.In the morning, patient woke up with a blood glucose level above 600 mg/dl and was vomiting.When patient went with the ems, the pump was still connected to the patient and they removed the pump.At that time, they noticed that the tubing that come out at the end, it was broken.Patient had a blood glucose above 1500 mg/dl when he died.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: 7581427
• MDR Text Key: 110448719
• Report Number: 3003442380-2018-00023
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244006416
• UDI-Public: 05705244006416
• 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: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2018
• 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