MAUDE Adverse Event Report: QUICK SET PARADIGM; UNO QUICK-SET 110/9 SC1 MECA

Lot Number UNKNOWN

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.On (b)(6) 2024, it was reported that the patient's infusion set had fallen off (tape was not sticking) while she was sleeping, and her daughter found it in her bed which led to high blood glucose level and he could not even walk (shakiness).Therefore, she went to the hospital on (b)(6) 2024 at 11:00 am or 12:00 pm due to diabetic ketoacidosis.The blood glucose level of the patient at the time of hospitalization was 800 mg/dl.During hospital, she received insulin drip intravenously as corrective treatment.The patient was hospitalized for four days.No further information was available.

• Brand Name: QUICK SET PARADIGM
• Type of Device: UNO QUICK-SET 110/9 SC1 MECA
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18756277
• MDR Text Key: 335935267
• Report Number: 3003442380-2024-00160
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 02/17/2024
• Patient Sequence Number: 1