MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; UNO QUICK-SET 60/6 SC1 MECA

Model Number MMT-399A

Device Problem Material Twisted/Bent (2981)

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, the patient's father reported that his daughter experienced nausea, vomiting, abdominal pain and difficulty in breathing.At the time of the incident, her blood glucose level was 350 mg/dl and she was using an insulin pen.Further, she was admitted to the hospital with blood glucose level of 700 and diabetic ketoacidosis.Moreover, she was taking shots and was hospitalized for seven days.Currently, (at the time of the call), her blood glucose level was 233 mg/dl.Upon visual inspection of the returned used device (two sets), it was found that the soft cannula was kinked (at the tip and the middle).Unomedical do not see bent/kinking as being related to human factors, but rather as a training issue including correct choices of insertion sites and infusion sets and cannula length.Furthermore, the soft cannula is a flexible material that during use and upon removal can bend slightly.No further information available.

Event Description

On 04-apr-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.On (b)(6) 2021, the patient's father reported that his daughter experienced nausea, vomiting, abdominal pain and difficulty in breathing.At the time of the incident, her blood glucose level was 350 mg/dl and she was using an insulin pen.Further, she was admitted to the hospital with blood glucose level of 700 and diabetic ketoacidosis.Moreover, she was taking shots and was hospitalized for seven days.Currently, (at the time of the call), her blood glucose level was 233 mg/dl.Upon visual inspection of the returned used device (two sets), it was found that the soft cannula was kinked (at the tip and the middle).Unomedical do not see bent/kinking as being related to human factors, but rather as a training issue including correct choices of insertion sites and infusion sets and cannula length.Furthermore, the soft cannula is a flexible material that during use and upon removal can bend slightly.No further information available.

• Brand Name: QUICK-SET® PARADIGM®
• Type of Device: UNO QUICK-SET 60/6 SC1 MECA
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 11830274
• MDR Text Key: 250816651
• Report Number: 3003442380-2021-00248
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244017436
• UDI-Public: 5705244017436
• 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: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 09/01/2023
• Device Model Number: MMT-399A
• Device Lot Number: 5334677
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2022
• Patient Sequence Number: 1