MAUDE Adverse Event Report: UNOMEDICAL A/S INSET INFUSION SET

Lot Number UNKNOWN

Device Problems Material Twisted/Bent (2981); Insufficient Information (3190)

Patient Problems Hyperglycemia (1905); Coma (2417)

Event Date 10/15/2018

Event Type  Injury  

Manufacturer Narrative

Unomedical expect to submit a final emdr report within the following 30 days.

Event Description

Unomedical reference number: (b)(4).A (b)(6) female diabetic patient is receiving insulin treatment via a tandem insulin pump and an inset infusion set (tandem autosoft xc).The patient is taken to er with a blood glucose above 600 mg/dl and goes into coma 45 mins after admission on (b)(6) 2018.She is treated in hospital with i.V.Drip with insulin for 2.5 days.She is released on (b)(6) 2018.Patient receives medical follow-up for enlarged liver due to coma.When hospital staff removed her pump and infusion set they noticed a kinked soft cannula.Tandems reference number for this case is: (b)(4).

Manufacturer Narrative

Unomedical expect to submit a final emdr report within the following 30 days.(b)(6) 2019: unomedical is still trying to obtain more information on this case.We will submit a final emdr report within the coming 30 days.(b)(6) 2019: unomedical has not been able to obtain further, relevant information.Causal relation between infusion set and the incident remain unclear.We close the case now.If we should get new relevant information, we will re-open the case and provide fda with a new follow-up emdr submission.

Event Description

Unomedical reference number: 1117846 a 20-year old female diabetic patient is receiving insulin treatment via a tandem insulin pump and an inset infusion set (tandem autosoft xc).The patient is taken to er with a blood glucose above 600 mg/dl and goes into coma 45 mins after admission on (b)(6) 2018.She is treated in hospital with i.V.Drip with insulin for 2.5 days.She is released on (b)(6) 2018.Patient receives medical follow-up for enlarged liver due to coma.When hospital staff removed her pump and infusion set they noticed a kinked soft cannula.Tandems reference number for this case is: com-302858.

Manufacturer Narrative

Unomedical expect to submit a final emdr report within the following 30 days.(b)(6) 2019: unomedical is still trying to obtain more information on this case.We will submit a final emdr report within the coming 30 days.

Event Description

Unomedical reference number: (b)(4).A 20-year old female diabetic patient is receiving insulin treatment via a tandem insulin pump and an inset infusion set (tandem autosoft xc).The patient is taken to er with a blood glucose above 600 mg/dl and goes into coma 45 mins after admission on (b)(6) 2018.She is treated in hospital with i.V.Drip with insulin for 2.5 days.She is released on (b)(6) 2018.Patient receives medical follow-up for enlarged liver due to coma.When hospital staff removed her pump and infusion set they noticed a kinked soft cannula.Tandems reference number for this case is: (b)(4).

• Brand Name: INSET INFUSION SET
• Type of Device: INSET INFUSION SET
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, DK-43 20; DA DK-4320
• MDR Report Key: 8099715
• MDR Text Key: 128199914
• Report Number: 3003442380-2018-00032
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 20 YR