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

Model Number MMT-941

Device Problem No Apparent Adverse Event (3189)

Patient Problems Death (1802); Hyperglycemia (1905); Diabetic Ketoacidosis (2364)

Event Date 07/10/2016

Event Type  Death  

Manufacturer Narrative

On (b)(6) 2016 clinical evaluation: wife of a male diabetic patient contacts medtronic's helpdesk to inform that her husband passed away 2 months earlier after being hospitalised following a day of rising blood glucose level ending with diabetic ketoacidosis.Patient remained on pump therapy in hospital until death one day later when blood glucose was recorded at 33 mmol/l.Wife informs that her husband was recently diagnosed with multiple sclerosis.Wife does not allege any malfunctions of insulin pump and/or infusion set related to the death of her husband.Insulin pump and infusion set remained at hospital, thus no pump history nor examination of infusion set is available/possible.With the presently available information, it is not possible to perform a proper clinical evaluation.Should further, relevant information become available, unomedical will re-open the case and inform, by follow-up reports, the (b)(6) and the us fda as appropriate.

Event Description

(b)(4) - case concerns a (b)(6) citizen and occurred in the (b)(6).Wife of a male diabetic patient contacts medtronic's helpdesk to inform that her husband passed away 2 months earlier after being hospitalised following a day of rising blood glucose level ending with diabetic ketoacidosis.Patient remained on pump therapy in hospital until death one day later when blood glucose was recorded at 33 mmol/l.Wife informs that her husband was recently diagnosed with multiple sclerosis.Wife does not allege any malfunctions of insulin pump and/or infusion set related to the death of her husband.

• Brand Name: MIO INFUSION SET
• Type of Device: INFUSION SET
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer (Section G): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320 ; 548167000
• MDR Report Key: 5969425
• MDR Text Key: 55313102
• Report Number: 3003442380-2016-00014
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051264
• 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: 09/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2019
• Device Model Number: MMT-941
• Device Lot Number: 5141601
• Date Manufacturer Received: 09/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization