MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; QUICK-SET 60/6 PCC

Lot Number UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.The patient's mother reported that the patient had high blood glucose level (over 600 mg/dl) and had no back up plan.Reportedly, the blood glucose was 600 mg/dl at the time of the event and currently it was 135 mg/dl.The high blood glucose level was treated in the emergency room after the pump failed to treat.The patient was admitted in the intensive care unit and received an unspecified drug via intravenous drip to stabilize and then went back on pump but had another spike and was now back in intensive care unit.The patient was hospitalized since two days.It was also reported that the patient had changed the set a day prior to this report but had high blood glucose level without changing the set.It was also noticed that the site was sore, and the patient had issues before at site.No further information available.

• Brand Name: QUICK-SET® PARADIGM®
• Type of Device: QUICK-SET 60/6 PCC
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 8517127
• MDR Text Key: 142038306
• Report Number: 3003442380-2019-01165
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244006331
• UDI-Public: 05705244006331
• 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
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 03/29/2017
• Type of Device Usage: N
• Patient Sequence Number: 1