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

Model Number MMT-399

Device Problem No Apparent Adverse Event (3189)

Patient Problem Death (1802)

Event Date 12/03/2016

Event Type  Death  

Manufacturer Narrative

28-feb-2017: 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 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: the spouse of patient informed that patient had passed away.Patient went to bed, and did not wake up.There are no information of patients blood glucose level at time of death, no clinical symptoms up to death was noticed and the spouse did not report any indications of pump or infusion set malfunction.No used infusion set was returned for testing and due to no lot number reported no reference samples were tested.If new information becomes available this case will be reevaluated.

Event Description

(b)(4).On (b)(6) 2016 a female diabetic patient on pump therapy passed away at home.The spouse of the patient reported the patient went to bed and did not wake up.The patient was wearing pump at time of death.The blood glucose level at time of death is unknown.Official cause of death is diabetes mellitus type 1.No other complications have been reported.No further information available.

• Brand Name: QUICK-SET PARADIGM INFUSION SET
• Type of Device: QUICK- SET 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 ; 548167000
• MDR Report Key: 6363767
• MDR Text Key: 68469364
• Report Number: 3003442380-2017-00005
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991759
• 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: 02/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: MMT-399
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death