MAUDE Adverse Event Report: SURE-T PARADIGM; UNO CONTACT DETACH G29 60/6 PCC MIMX

Lot Number	UNKNOWN
Medical Device Problem Codes	Device Difficult to Program or Calibrate (1496); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Type of Reportable Event	Serious Injury
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in hong kong.On 27-jan-2024, the patient's parent reported that their child's infusion set needle had broken off while the implant was in the abdomen.There was no needle when infusion set was removed, but the implant site felt itchy and hard bulge was seen under the skin.Moreover, the infusion set had been used for 3 days.Therefore, the parents took the child for computed tomography (ct) scan and on 24-jan-2024 at 23:17 pm, the test results confirmed that the broken needle was under the skin.Moreover, the child's blood glucose level was 20 mmol/l and insulin pump were used to control blood glucose level.Further, on 25-jan-2024 at noon, it was informed that the needle was surgically removed in the hospital.No further information was available.
Additional Manufacturer Narrative
Correction: this mdr is being submitted to correct the submitted medical device problem code under h6.Unomedical hereby submits this supplemental report as part of its complaint remediation activities conducted under a capa/fda action plan.This submission includes a retrospective reassessment of previously evaluated complaints.Unomedical is providing this supplemental information in accordance with the reporting requirements set forth in 21 cfr part 803.Any fields left blank indicate that the information is unknown, unavailable, or remains unchanged.Additional information - this mdr is being submitted to include the below: h6: investigation results under type of investigation, investigation findings, investigation conclusions.H11: investigation summary.Complaint investigation results: upon review of the event description and assigned malfunction code misuse.Malfunction code not on list.Additional information was requested; however, a lot number was not provided.No device, device components, or other visual or physical evidence was made available for evaluation.Consequently, visual inspection, retain-sample testing, or the assessment of potential product performance issues, component integrity, or manufacturing defects could not be performed.Therefore, no additional investigation activities were required.Corrective and preventive action (capa) plan determination: based on the investigation, no further action is required.The record will be closed and monitored through tracking and trending per work instruction (wi) (monthly trips and alerts).Complaint unconfirmed: following investigation, the reported failure could not be confirmed for this complaint.Complaint investigation - conclusion: based on the event description, assigned malfunction code, and limited information available, the reported failure could not be confirmed for this complaint.
Event or Problem Description
To date no additional patient or event details have been received.

• Brand Name: SURE-T PARADIGM
• Common Device Name: UNO CONTACT DETACH G29 60/6 PCC MIMX
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18634243
• Report Number: 3003442380-2024-00136
• Device Sequence Number: 18165721
• Product Code: FPA
• UDI-Device Identifier: 05705244005778
• UDI-Public: 05705244005778
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026

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 Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2024
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 02/02/2024
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown