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

Model Number MMT-397

Device Problem No Apparent Adverse Event (3189)

Patient Problem Death (1802)

Event Date 04/12/2016

Event Type  Death  

Manufacturer Narrative

On (b)(6) 2016: unomedical (b)(4) is actively seeking further information on this incident.Unomedical is expected to submit a follow-up (or final) emdr report not later than 13-jun-2016.

Event Description

Unomedical reference number: (b)(4).The sister reported death of her diabetic sister on pump therapy at home on (b)(6) 2016.The sister reported that in the morning the patient was not in bed and the roommate went into the room and found the patient not breathing.Cause of death is unknown.No official cause of death reported.Roommate not sure if cause of death was low blood glucose or heart attack.Patient was wearing pump and infusion set at time of death.The pump was beeping.The last blood glucose level was 168 mg/dl and was recorded in logbook on (b)(6) 2016 at 09:43 pm.No further information available.

Manufacturer Narrative

Update 26-may-2016: the reference samples were visually inspected and tested for flow, leak and ventilation to the pcap.All test results were within specifications.The batch record 5132555 was verified and found it within specifications.Based on the investigation and test results the claimed failure can not be confirmed.If new information becomes available the complaint will be re-opened and appropriate actions will be taken.Clinical evaluation: the chain of events regarding the death of this patient is not clear.Patient experienced several health consequences (transplantation, heart disease, infection) possibly due to the diabetes.Not enough information is available to determine if the death is connected to insulin pump use.Not enough information to perform a clinical evaluation.

Event Description

(b)(4).The sister reported death of her diabetic sister on pump therapy at home on (b)(6) 2016.The sister reported that in the morning the patient was not in bed and the roommate went into the room and found the patient not breathing.The official cause of death was natural causes or heart attack.Roommate not sure if cause of death was low blood glucose or heart attack.Patient was wearing pump and infusion set at time of death.The pump was beeping.The last blood glucose level was 168 mg/dl and was recorded in logbook on (b)(6) 2016 at 09:43 pm.No further information available.

• Brand Name: QUICK-SET PARADIGM
• 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: 5646304
• MDR Text Key: 44981803
• Report Number: 3003442380-2016-00006
• 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,Followup
• Report Date: 05/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2016
• 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: 5132555
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2016
• 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