MAUDE Adverse Event Report: UNOMEDICAL A/S SILHOUETTE PARADIGM INFUSION SET

Model Number MMT-381600

Device Problem No Apparent Adverse Event (3189)

Patient Problem Death (1802)

Event Date 12/08/2016

Event Type  Death  

Manufacturer Narrative

On 13-mar-2017: the reference samples were visually inspected and tested for flow, leak and ventilation.All test results were within specifications.The batch record # 5153349 is verified and found within specifications.The claimed failure cannot be confirmed.An investigation has been performed based on the customer complaint description and the reference samples from the same lot number.According to unomedical's traceability records, no relevant deviations were found.If new information becomes available, the complaint will be re-opened and appropriate actions will be taken.Unomedical is actively seeking more information about this incident and will no later than 18-apr-2017 send follow up or final mdr report.

Event Description

(b)(4).This incident occurred in (b)(6).A female diabetic patients death was reported by her mother.Date of death was (b)(6) 2016.Patients mother stated that she was not careful with her diabetes and death was not due to diabetes.She did not recall if patient was wearing pump at time of death.She noted her daughter died around lunch time on (b)(6) 2016 and she found her in her apartment on (b)(6) 2016.Doctors (b)(6).No further information available.

Manufacturer Narrative

On 13-mar-2017: the reference samples were visually inspected and tested for flow, leak and ventilation.All test results were within specifications.The batch record # 5153349 is verified and found within specifications.The claimed failure cannot be confirmed.An investigation has been performed based on the customer complaint description and the reference samples from the same lot number.According to unomedical's traceability records, no relevant deviations were found.If new information becomes available, the complaint will be re-opened and appropriate actions will be taken.On 25-apr-2017: clinical evaluation: the mother of deceased patient contacted call center to return unused supplies.The mother of patient described patient had died due to diabetes and was found death in patients apartment.The mother of patient stated that the daughter was not careful with her diabetes.The mother of patient do not recall if patient was wearing pump at time of death.No additional information is provided after repeatedly asking for more information.No used infusion set has been returned for testing.There is no indication that infusion set has malfunctioned or any use error related to use of infusion set.Not enough information available to perform a clinical evaluation of the event leading to death.If new information becomes available this case will be reopened.

Event Description

(b)(4).This incident occurred in (b)(6).A female diabetic patients death was reported by her mother.Date of death was (b)(6) 2016.Patients mother stated that she was not careful with her diabetes and death was due to diabetes.She did not recall if patient was wearing pump at time of death.She noted her daughter died around lunch time on (b)(6) 2016 and she found her in her apartment on (b)(6) 2016.(b)(6).No further information available.

• Brand Name: SILHOUETTE PARADIGM INFUSION SET
• Type of Device: SILHOUETTE PARADIGM 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: 6398583
• MDR Text Key: 69746426
• Report Number: 8021545-2017-00004
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162812
• 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: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 07/30/2020
• Device Model Number: MMT-381600
• Device Lot Number: 5153349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2017
• 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