MAUDE Adverse Event Report: QUICK SET PARADIGM; UNO QUICK-SET 60/9 SC1 MECA

Lot Number UNKNOWN

Device Problem Infusion or Flow Problem (2964)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.On 04-mar-2024, it was reported that the patient faced an insulin flow blockage on (b)(6) 2024 and chest pain.The patient reported that her blood glucose level started getting high on (b)(6) 2024, went high on (b)(6) 2024 and she experienced pressure on chest.Therefore, on the same day of the event ((b)(6) 2024), at 07:00 pm, she was admitted to hospital with blood glucose level over 1000 mg/dl.During hospitalization, the patient received insulin intravenously (intravenous insulin infusion) as corrective treatment.At the time of this report,the patient was still in the hospital.No further information was available.

• Brand Name: QUICK SET PARADIGM
• Type of Device: UNO QUICK-SET 60/9 SC1 MECA
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18884034
• MDR Text Key: 337411414
• Report Number: 3003442380-2024-00181
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K160648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 03/05/2024
• Patient Sequence Number: 1