MAUDE Adverse Event Report: UNOMEDICAL A/S MEDTRONIC INFUSION SET QUICK-SET PARADIGM; INSULIN INFUSION SET

Model Number MMT-397

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Hypoglycemia (1912)

Event Date 09/17/2017

Event Type  Death  

Manufacturer Narrative

Together with medtronic unomedical is still trying to obtain further information and, possibly, also to obtain the infusion set used at time of the primary incident.If new, relevant information becomes available, we will reopen the case and act appropriately, including providing a follow-up report to fda.It is however increasing likely that we will not be able to more information.

Event Description

(b)(4).Note: this case involves (b)(6) citizen and occurs in the (b)(6).A female diabetic patient is receiving insulin via a medtronic insulin pump and a medtronic quick-set infusion set.The (b)(6) reports some details from a 'user report' including that on (b)(6) 2017 a 'suspected faulty' infusion set allegedly may have delivered excessive insulin resulting in hypoglycemia, brain damage and lastly, on (b)(6) 2017, death.Even after initial medtronic local investigations in (b)(6), there is confusion on many details, including pump (and infusion set) location(s).A (b)(6) coroner refer to two different hospitals - who both refer back to the coroner.Medtronic staff is continuing in their efforts to provide further information.Analysis of the pump's internal memory could provide important data.Likewise, investigation of the infusion set used at time of the primary incident on (b)(6) 2017 may provide important data.Infusion set lot number: not known exactly, but probably one of: (b)(4).

• Brand Name: MEDTRONIC INFUSION SET QUICK-SET PARADIGM
• 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: 7240420
• MDR Text Key: 98972834
• Report Number: 3003442380-2018-00009
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244006492
• UDI-Public: 05705244006492
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160648
• 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: 02/05/2018

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: MMT-397
• Device Lot Number: SEE NARRATIVE DESCR.
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/23/2017
• 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; Life Threatening