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

Lot Number	UNKNOWN
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hypoglycemia (1912)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the netherlands.It was reported that the patient faced an insulin delivery issue and stated that insulin was dripping or squirting from the end of the set during the last set change before connecting it at the customer's site.A low blood glucose event (low bgs) was reported by the patinet, who experienced a significant health risk due to the insulin delivery issue.However, they treated the low blood glucose (low bg) event by consuming some carbohydrates.No further information available.

• 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: 19327928
• Report Number: 3003442380-2024-01628
• Device Sequence Number: 19608382
• Product Code: FPA
• UDI-Device Identifier: 05705244005778
• UDI-Public: 05705244005778
• 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?: No
• Is this a Product Problem Report?: Yes
• 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