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 (b)(6).On (b)(6) 2021, it was reported that a child patient experienced high blood glucose level of 533 mg/dl due to a bent cannula but had no insulin flow blocked alarm.Consequently, on (b)(6) 2021 at 21:00, the patient was admitted to the hospital due to vomiting, blood glucose level of 533 mg/dl and ketones as 4.8 mmol/l.During hospitalization, the patient was administered insulin drip as corrective treatment.On (b)(6) 2021, the patient was released from the hospital.Currently, the patient's blood glucose level was 281 mg/dl.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 iv: 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, it was reported that a child patient experienced high blood glucose level of 533 mg/dl due to a bent cannula but had no insulin flow blocked alarm.Consequently, on (b)(6) 2021 at 21:00, the patient was admitted to the hospital due to vomiting, blood glucose level of 533 mg/dl and ketones as 4.8 mmol/l.During hospitalization, the patient was administered insulin drip as corrective treatment.On (b)(6) 2021, the patient was released from the hospital.Currently, the patient's blood glucose level was 281 mg/dl.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: 12596883
• MDR Text Key: 275367651
• Report Number: 3003442380-2021-00549
• 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: 10/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 03/01/2023
• Device Model Number: MMT-399A
• Device Lot Number: 5348473
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2022
• Patient Sequence Number: 1