MAUDE Adverse Event Report: UNOMEDICAL A/S QUICK SET PARADIGM (NO DETAILS OF INFUSION SET USED HAS BEEN REPORTED)

Model Number MMT-399

Device Problem No Apparent Adverse Event (3189)

Patient Problems Death (1802); Hypoglycemia (1912)

Event Date 09/08/2014

Event Type  Death  

Manufacturer Narrative

No relevant testing could be performed.If lot information was available, the batch records and the complaint database were reviewed for relevant deviations and similar complaints.This case has been closed due to missing information.No relevant testing could be performed.Since infusion set type and the lot number is unknown, no batch record review or testing of retained samples could be performed.If the lot number becomes available, the case will be re-opened and appropriate actions will be taken.Clinical evaluation: it is reported that patient was found unresponsive in his home due to severe hypoglycemia.Due to the hypoglycemia patient got altered mental status and died (b)(6) 2015 because of complications.It is not reported from pump history if patient have tried to take a bolus, or receiving any alarm.

Event Description

(b)(4).On (b)(6) 2014 the patient was found unresponsive at home.Paramedics were unable to obtain a blood glucose reading and he was admitted to the intensive care unit at the hospital ( (b)(6) hospital) with severe hypoglycemia and seizures due to low blood glucose level.Due to the hypoglycemia patient got altered mental status and died (b)(6) 2015 because of complications.No exact details was provided concerning which infusion set was actually used by user.No further information available.This event was reported by legal representative via medtronic.

• Brand Name: QUICK SET PARADIGM (NO DETAILS OF INFUSION SET USED HAS BEEN REPORTED)
• Type of Device: QUICK 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: 5219271
• MDR Text Key: 30966130
• Report Number: 3003442380-2015-00022
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011071
• 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: 11/11/2015

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: Lay User/Patient
• Device Model Number: MMT-399
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/20/2015
• Initial Date FDA Received: 11/12/2015
• 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; Hospitalization