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

Model Number 1000283

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 experienced high blood glucose level due to a kinked cannula because of this the insulin was not being delivered to the patient and the insulin was bad.Therefore, he tried to treat it with bolus via the pump several times, but the blood glucose level was not going down.Subsequently, on (b)(6) 2021, the patient was admitted to the hospital due to diabetic ketoacidosis and high blood glucose level.His highest blood glucose level was over 600 mg/dl.During hospitalization, the pump was removed, insulin, fluids of saline and unspecified intravenous medication (drug name unknown) were administered as corrective treatment, which resolved the issue.On (b)(6) 2021, the patient was released from the hospital with no permanent damage.Moreover, the patient reported that since (b)(6) (previously), he had experienced diabetic ketoacidosis three time and for each time he had been hospitalized.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 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: 11722807
• MDR Text Key: 247754705
• Report Number: 3003442380-2021-00226
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244014664
• UDI-Public: 05705244014664
• Combination Product (y/n): Y
• PMA/PMN Number: K061374
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial

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 Operator: No Information
• Device Model Number: 1000283
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 04/15/2021
• Initial Date FDA Received: 04/26/2021
• Type of Device Usage: N
• Patient Sequence Number: 1