MAUDE Adverse Event Report: SURE-T® PARADIGM®; UNO CONTACT DETACH G29 80/6 PCC MIMX

Model Number	MMT-866
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Type of Reportable Event	Serious Injury
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in (b)(6).On (b)(6) 2022, it was reported that a (b)(6) male (thin body) patient with type 2 diabetes was admitted in the hospital.Previously, (b)(6) 2022, the patient was given a pump infusion of insulin to control his blood glucose level and a subcutaneous implantation of an infusion line in the patient's abdomen.Therefore, his blood glucose value was measured in the afternoon of the next day which showed 20 mmol/l.The hospital immediately corrected it by insulin number when he used the bolus but did not achieve the expected effect.On the morning of the 1st ((b)(6) 2022) the nurse found that the missing needle was found when changing the needle and after taking the film at about 11 o'clock on the same day it was found that there was a foreign body under the skin of the abdomen and the hospital arranged for surgery to take the needle in the afternoon of the same day.No further information available.

• Brand Name: SURE-T® PARADIGM®
• Common Device Name: UNO CONTACT DETACH G29 80/6 PCC MIMX
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 14386213
• Report Number: 3003442380-2022-00654
• Device Sequence Number: 11967112
• Product Code: FPA
• UDI-Device Identifier: 05705244006058
• UDI-Public: 05705244006058
• Combination Product (Y/N): Y
• 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
• Report Date (Section B): 05/13/2022

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 Expiration Date: 08/01/2023
• Device Model Number: MMT-866
• Device Lot Number: 5333045
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 05/12/2022
• Patient Sequence Number: 1
• Patient Sex: Unknown