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

Lot Number 6001417

Device Problem Material Twisted/Bent (2981)

Patient Problem Diabetic Ketoacidosis (2364)

Event Date 12/27/2023

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states on (b)(6) 2023, it was reported that the patient faced a bent cannula due to which she experienced high blood glucose level and diabetic ketoacidosis.Her sensor read 200 mg/dl, but her blood glucose level was 529 mg/dl.Therefore, on (b)(6) 2023 at 03:00 pm, the patient was admitted to the hospital due to diabetic ketoacidosis with blood glucose level of 865 mg/dl and sensor glucose was 200 mg/dl.She stayed for two days in the hospital.Currently, her blood glucose level was 147 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 was 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: a3: sex.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 60/9 SC1 MECA
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18463234
• MDR Text Key: 332262309
• Report Number: 3003442380-2024-00112
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244017573
• UDI-Public: 05705244017573
• Combination Product (y/n): N
• 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: 6001417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/30/2023
• Initial Date FDA Received: 01/08/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2023
• 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
• Patient Sex: Female