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

Model Number	MMT-866
Medical Device Problem Code	Infusion or Flow Problem (2964)
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 the united states.On (b)(6) 2022, it was reported that the patient experienced shortness of breath, fatigue and chest pain because of an insulin flow blocked alarm.The infusion set had been used for a couple of hours.Consequently, on (b)(6) 2022, the patient was admitted in the hospital as the blood glucose level was 744 mg/dl and ketones were 80 mmol/l.Moreover, the patient experienced diabetic ketoacidosis and was released after three days.Currently, the patient's blood glucose level was 102 mg/dl.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: 13439768
• Report Number: 3003442380-2022-00244
• Device Sequence Number: 4327886
• 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): 02/03/2022

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: 04/01/2022
• Device Model Number: MMT-866
• Device Lot Number: 5272490
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2022
• Initial Report FDA Received Date: 02/03/2022
• Patient Sequence Number: 1
• Patient Sex: Unknown