MAUDE Adverse Event Report: AUTOSOFT 90; UNO INSET II 60/6 GREY TCAP 10PK INT

Lot Number 6001875

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.It was reported that the patient's infusion set fell off during use with two similar types of infusion sets (during (b)(6) 2024 to (b)(6) 2024) due to which she experienced high blood glucose level.Therefore, they tried to treat it with bolus via pump and multiple daily injection, but on (b)(6) 2024, she first went to emergency room and was subsequently hospitalized due to high blood glucose level.Her highest blood glucose level was 488 mg/dl and had high ketone level which healthcare professional did not assess as dangerous or life-threatening.Moreover, the infusion had been used for three days.During hospitalization, the patient received fluids of saline, insulin, and unspecified medication (drug name unknown) intravenously as corrective treatment which resolved the issue.On (b)(6) 2024, the patient was released from the hospital with no permanent damage.No further information was available.

• Brand Name: AUTOSOFT 90
• Type of Device: UNO INSET II 60/6 GREY TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18884051
• MDR Text Key: 337413465
• Report Number: 3003442380-2024-00182
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K032854
• 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: 6001875
• Date Manufacturer Received: 03/05/2024
• Patient Sequence Number: 1