MAUDE Adverse Event Report: UNOMEDICAL A/S A MEDTRONIC INSULIN INFUSION SET (UNKNOWN TYPE AND MODEL)

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 09/07/2016

Event Type  Death  

Manufacturer Narrative

Currently medtronic is unable to provide unomedical with any further information.If new, relevant information become available, we will update the case accordingly and provide fda with a follow-up mdr.

Event Description

(b)(4).A male diabetic patient receives insulin via a medtronic insulin pump (mmt-751) and a medtronic insulin infusion set (unknown type and model).On the day of (b)(6) 2016, the parents find their son lifeless (un-wakeable) with blue lips, still wearing the pump and a mounted infusion set.His body arrives at a local hospital at 13:12 in the afternoon.Patient is then declared dead.Whether a blood glucose sensor was used remains unknown.There is no information about any bg readings around time of the incident.There is no data suggesting an infusion set failure/malfunction.Determination of cause of death is still pending - it is known, that the patient had an 'enlarged heart'.It is also known, that the patient was seeing a 'head doctor' due to a concussion occurred during playing football and started having 'seizures'.The case is presently involved in legal litigation.(b)(4).

• Brand Name: A MEDTRONIC INSULIN INFUSION SET (UNKNOWN TYPE AND MODEL)
• Type of Device: INSULIN 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
• MDR Report Key: 6995651
• MDR Text Key: 90832763
• Report Number: 3003442380-2017-00017
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN SET
• 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: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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