MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; UNO QUICK-SET 46/6 SC1 MECA

Model Number MMT-394A

Device Problem Material Twisted/Bent (2981)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in (b)(6).On 19-aug-2021, the patient's mother reported that her daughter felt sick, experienced headache due to high blood glucose levels which was due to a bent cannula.Subsequently, on (b)(6) 2021, she was admitted to the hospital with blood glucose level above 500 mg/dl and ketones as 31.07 mg/dl (result 2,2).During hospitalization, she was administered insulin via pen, and she stayed in the hospital for three days.Currently, her blood glucose level was 213 mg/dl (after meal).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 germany.On (b)(6) 2021, the patient's mother reported that her daughter felt sick, experienced headache due to high blood glucose levels which was due to a bent cannula.Subsequently, on (b)(6) 2021, she was admitted to the hospital with blood glucose level above 500 mg/dl and ketones as 31.07 mg/dl (result 2,2).During hospitalization, she was administered insulin via pen, and she stayed in the hospital for three days.Currently, her blood glucose level was 213 mg/dl (after meal).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 46/6 SC1 MECA
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 12432338
• MDR Text Key: 270057403
• Report Number: 3003442380-2021-00443
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244017313
• UDI-Public: 5705244017313
• 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: 09/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 03/01/2024
• Device Model Number: MMT-394A
• Device Lot Number: 5348413
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2022
• Patient Sequence Number: 1