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

Model Number MMT-397A

Device Problem Material Deformation (2976)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.It was reported that the patient experienced a bent tubing issue which led to blood glucose level of 349 mg/dl.On (b)(6) 2021, the patient was admitted to the hospital with blood glucose level of 600 mg/dl and diabetic ketoacidosis.During hospitalization, the patient was administered intravenous insulin infusion.The patient was hospitalized for two days.Currently, the patient's blood glucose level was 600 mg/dl.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 united states.It was reported that the patient experienced a bent tubing issue which led to blood glucose level of 349 mg/dl.On (b)(6) 2021, the patient was admitted to the hospital with blood glucose level of 600 mg/dl and diabetic ketoacidosis.During hospitalization, the patient was administered intravenous insulin infusion.The patient was hospitalized for two days.Currently, the patient's blood glucose level was 600 mg/dl.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: 11588020
• MDR Text Key: 242904161
• Report Number: 3003442380-2021-00194
• 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: 03/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 06/01/2023
• Device Model Number: MMT-397A
• Device Lot Number: 5321849
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2022
• Patient Sequence Number: 1