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

Lot Number	UNKNOWN
Medical Device Problem Code	No Apparent Adverse Event (3189)
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 china.On (b)(6) 2024, it was reported that patient was hospitalized due to high blood glucose level (around 22.2 mmol/l).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: 19328737
• Report Number: 3003442380-2024-01851
• Device Sequence Number: 6910875
• Product Code: FPA
• UDI-Device Identifier: 05705244006058
• UDI-Public: 05705244006058
• Combination Product (Y/N): N
• 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): 05/16/2024

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 Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 05/16/2024
• Patient Sequence Number: 1
• Patient Sex: Unknown