MAUDE Adverse Event Report: UNOMEDICAL A/S MIO; INSET

Model Number MMT-975

Device Problem No Apparent Adverse Event (3189)

Patient Problem Death (1802)

Event Date 08/04/2015

Event Type  Death  

Manufacturer Narrative

The claimed failure cannot be confirmed.The complaint has been reviewed based on the customer complaint description and evaluates that no further investigation can be performed before either used samples are received for testing or that the lot number is provided to investigate a potential origin of the product failure in the devices manufacturing traceability documents.It is by the existing data available not possible to make an adequate clinical evaluation: patient's wife reported that her husband died from a stroke.There is not reported any symptoms of diabetic ketoacidosis, last blood glucose reading was 282mg/dl (the date of this reading is not reported) blood glucose at time of dead is not available.There is no information regarding infusion set reported, nor is medical report or autopsy available.

Event Description

(b)(4).Diabetic male patient treated with insulin via pump and infusion set died from a stroke at home on (b)(6) 2015.There is not reported any symptoms of diabetic ketoacidosis, last blood glucose reading was 282mg/dl (the date of this reading is not reported) blood glucose at time of dead is not available.There is no information regarding infusion set reported, nor is medical report or autopsy available.

Manufacturer Narrative

Additional information 01/20/2016: a visual inspection and a test for flow, ventilation and leak were performed on the returned used device (1 set inserted) the results were found within specifications.Based on the investigation and test results the claimed failure can not be confirmed.If new information becomes available the complaint will be re-opened and appropriate actions will be taken.Clinical evaluation: it is by the existing data available not possible to make an adequate clinical evaluation: patient's wife reported that her husband died from a stroke.There is not reported any symptoms of diabetic ketoacidosis, last blood glucose reading was 282 mg/dl (the date of this reading is not reported) blood glucose at time of death is not available.There is no information regarding infusion set reported, nor is medical report or autopsy available.

Event Description

(b)(4).Diabetic male patient treated with insulin via pump and infusion set died from a stroke at home on (b)(6) 2015.There is not reported any symptoms of diabetic ketoacidosis, last blood glucose reading was 282 mg/dl (the date of this reading is not reported) blood glucose at time of death is not available.There is no information regarding infusion set reported, nor is medical report or autopsy available.

• Brand Name: MIO
• Type of Device: INSET
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320 ; 548167000
• MDR Report Key: 5220596
• MDR Text Key: 31025921
• Report Number: 3003442380-2015-00020
• 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,Followup
• Report Date: 01/20/2016

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: MMT-975
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/29/2015
• Initial Date FDA Received: 11/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death