MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; UNO QUICK-SET 60/9 SC1 MECA

Model Number MMT-397A

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) 2021, it was reported that the patient felt sick/unwell, tired/weak body and did not want to work.Further, it was stated that the set came out of the body in the middle of the night, which she tried to treat with manual injection but, it would not bring blood glucose down.Consequently, on (b)(6) 2021, at 1:00 pm, the patient was admitted to the hospital due to high blood glucose level of 700 mg/dl and diabetic ketoacidosis.Subsequently, she was then transferred to the intensive care unit and stayed there for three days (from sunday to tuesday).During hospitalization, she received intravenous insulin infusion and was admitted for four days.No further information available.

Event Description

On 30-mar-2022 an: follow up information was submitted to update the unique identifier (udi) number and awareness date.Unomedical reference number (b)(4).Event occurred in the (b)(4).On (b)(6) 2021, it was reported that the patient felt sick/unwell, tired/weak body and did not want to work.Further, it was stated that the set came out of the body in the middle of the night, which she tried to treat with manual injection but, it would not bring blood glucose down.Consequently, on (b)(6) 2021, at 1:00 pm, the patient was admitted to the hospital due to high blood glucose level of 700 mg/dl and diabetic ketoacidosis.Subsequently, she was then transferred to the intensive care unit and stayed there for three days (from sunday to tuesday).During hospitalization, she received intravenous insulin infusion and was admitted for four days.No further information available.

• Brand Name: QUICK-SET® PARADIGM®
• Type of Device: UNO QUICK-SET 60/9 SC1 MECA
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 12251435
• MDR Text Key: 264250554
• Report Number: 3003442380-2021-00340
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244017559
• UDI-Public: 5705244017559
• 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,Followup
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 01/01/2024
• Device Model Number: MMT-397A
• Device Lot Number: 5344859
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2022
• Patient Sequence Number: 1