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

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Hypoglycemia (1912)

Event Date 11/22/2017

Event Type  Death  

Manufacturer Narrative

There are no allegations from the family that the infusion set contributed to the patient's death.Note: when this case was received by unomedical the initial information was, that the patient had not been using insulin pump therapy for the 22 days leading up to her death at home.Therefore, we at that time considered the death as totally unrelated to the use af any insulin pump infusion set.On 20-jan-2018 we learned that the patient - despite the opposite advise from medtronic helpdesk - had continued to use the old, presumed failing insulin pump.Therefore we have re-evaluated the reportability and are now mdr reporting this fatal incident to fda.We do not expect to receiver further information on this case.

Event Description

(b)(4).Medtronic helpdesk is contacted by patient's family (husband and son) informing the their wife/mother passed away on (b)(6) 2017.The patient was waiting to have her failing insulin pump replaced.While waiting, she had been advised not to use her insulin pump until the replacement pump had arrived.After 22 days, however, the patient was found dead at home, on the floor and wearing tho old pump.Pump was removed by her husband.There is no formal cause of death available, but the family states cause to be a very low level of blood glucose (husband states 0 mg/dl).Husband states, that the presumed failing insulin pump caused the death of his wife.It is not known whether the patient's cgm sensor was worn at time of death.Type of medtronic infusion set at time of death is not known.The patient bought her infusion sets and reservoirs from an independent retailer (i.E.Not via a medtronic subscription).

• Brand Name: MEDTRONIC INSULIN INFUSION SET - UNKNOWN TYPE/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: 7240302
• MDR Text Key: 98960270
• Report Number: 3003442380-2018-00006
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• 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: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death