MAUDE Adverse Event Report: AUTOSOFT 30; INSET 30 2-PACK 60/13 GREY TCAP

Lot Number UNKNOWN

Device Problem Material Twisted/Bent (2981)

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 faced a bent cannula which led to high blood glucose level.Therefore, they tried to treat it with bolus via pump, but on (b)(6) 2024, the patient first went to the emergency room and was subsequently hospitalized due to high blood glucose level.Her highest blood glucose level was 600 mg/dl and had diabetic ketoacidosis.Moreover, she was under other medications, an infection and underwent cancer therapy as she was recently diagnosed with cancer.Reportedly, the infusion had been used for three days, and the site location was patient's abdomen.During hospitalization, the patient received fluids of saline (unknown), insulin, potassium, magnesium and unspecified medication (drug name unknown) intravenously as corrective treatment which resolved the issue.On 06-feb-2024, the patient was released from the hospital with no permanent damage.Unomedical do not see bent/kinking as being related to human factors, but rather as a training issue including correct choices of insertion sites and infusion sets and cannula length.Furthermore, the soft cannula is a flexible material that during use and upon removal can bend slightly.No further information was available.

• Brand Name: AUTOSOFT 30
• Type of Device: INSET 30 2-PACK 60/13 GREY TCAP
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18786774
• MDR Text Key: 336282244
• Report Number: 3003442380-2024-00163
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K061374
• 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: 02/27/2024

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
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 02/27/2024
• Patient Sequence Number: 1