MAUDE Adverse Event Report: QUICK-SET® PARADIGM® UNO QUICK-SET 60/9 PCC MECA

Model Number MMT-397

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. On (b)(6) 2009, the patient's mother reported that her son was admitted in the hospital at 4:00 am, due to pancreatitis and diabetic ketoacidosis. Reportedly, he tried changing his set last night prior to going to hospital but his blood glucose level did not go down with pump, so he gave injections, and it came down a little. At the time of hospitalization, his blood glucose level was reported as 545 mg/dl. Currently, he is admitted in the intensive care unit and is administered insulin drip. Moreover, his mother stated that it did leak out near p-cap on quickset. No further information available.

• Brand Name: QUICK-SET® PARADIGM®
• Type of Device: UNO QUICK-SET 60/9 PCC MECA
• MDR Report Key: 12604693
• MDR Text Key: 275927851
• Report Number: 3003442380-2021-00567
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• PMA/PMN Number: K160648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 10/11/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: MMT-397
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No Answer Provided

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/03/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage