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

Lot Number 5363897

Device Problem Material Twisted/Bent (2981)

Patient Problem Diabetic Ketoacidosis (2364)

Event Date 01/01/2024

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in egypt.On (b)(6) 2024, it was reported that the patient felt sick, unwell, and experienced high blood glucose level.Therefore, they tried to treat it with manual injection/insulin pen.On (b)(6) 20234, the patient hospitalized due to high blood glucose level of 500 mg/dl (serum glucose level was above 400 mg/dl).The patient tested positive for ketone level.Moreover, the infusion set had been used for less than one hour.Further, the patient stated that when they removed the infusion set, they noticed it was bent.After staying for 6 days in the hospital, the patient was released.Currently, the blood glucose level was 160 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

Unomedical reference number (b)(4).To date no additional patient or event details have been received.

Manufacturer Narrative

Additional information - this emdr is being submitted to include the below fields as correction since these fields were missed in initial emdr: b6: relevant test data, d4: serial number, d5: operator of device, d7: is this a single-use device that was reprocessed and reused on a patient, d9: device available for evaluation, e1: name and address, e2: health professional, h4: device manufacture date, h5: labeled for single use, h8: usage of device.

• 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: 18532246
• MDR Text Key: 333088371
• Report Number: 3003442380-2024-00122
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244017450
• UDI-Public: 05705244017450
• Combination Product (y/n): Y
• Reporter Country Code: US
• 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: 05/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 5363897
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 01/18/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization