MAUDE Adverse Event Report: AUTOSOFT 90; INSET II 2-PACK 60/6 GREY TCAP

Lot Number UNKNOWN

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.The patient reported that the infusion set tubing was not connected to the site and that tubing on that infusion set was broken.Reportedly, her blood level was in the range of 170-200 mg/dl.It was stated that there was no damage when the package was first opened.No further information available.

• Brand Name: AUTOSOFT 90
• Type of Device: INSET II 2-PACK 60/6 GREY TCAP
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 9514532
• MDR Text Key: 183279041
• Report Number: 3003442380-2019-01990
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244014541
• UDI-Public: 05705244014541
• 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
• Type of Report: Initial

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 Operator: No Information
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/24/2019
• Type of Device Usage: N
• Patient Sequence Number: 1