MAUDE Adverse Event Report: UNOMEDICAL A/S SILHOUETTE PARADIGM; COMFORT

Model Number MMT-368

Device Problems Leak/Splash (1354); Cut In Material (2454); No Apparent Adverse Event (3189)

Patient Problem Death (1802)

Event Date 09/30/2015

Event Type  Death  

Manufacturer Narrative

On 18-mar-2016.Unomedical is actively seeking further information on the incident.Unomedical is expected to submit a follow-up (or final) emdr report not later than 19-apr-2016.Clinical evaluation 18-mar-2016: the mother reported death of daughter.Mother reported daughter experienced dangerous lows on and off over past 4 years when changing reservoir.Not enough information to perform a clinical evaluation.More information is necessary to evaluate incident and if death was or could be a result of pump or infusion set malfunction.

Event Description

Unomedical reference number: (b)(4).The mother reported death of her diabetic daughter on pump therapy at home on (b)(6) 2015.Mother reported daughter experienced dangerous lows on and off over past 4 years when changing reservoir.No official cause of death reported, but the mother feels like the low that occured after the daughter changed her reservoir killed her.The latest blood glucose level was 97 mg/dl and was recorded on (b)(6) 2015 at 08:17 pm.The patient was wearing pump at the time of death.No further information available.

Manufacturer Narrative

Updated information 18-apr-2016: the reference samples were visually inspected and tested for flow, leak and ventilation to pcc.All test results were within specifications.The batch record 5096428 was verified and found 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 18-apr-2016: questions regarding event was asked but it has not been possible to obtain any additional information.See clinical evaluation from 18-mar-2016 18-mar-2016 unomedical is actively seeking further information on the incident.Unomedical is expected to submit a follow-up (or final) emdr report not later than 19-apr-2016.Clinical evaluation 18-mar-2016: the mother reported death of daughter.Mother reported daughter experienced dangerous lows on and off over past 4 years when changing reservoir.Not enough information to perform a clinical evaluation.More information is necessary to evaluate incident and if death was or could be a result of pump or infusion set malfunction.

Event Description

(b)(4).The mother reported death of her diabetic daughter on pump therapy at home on (b)(6)2015.Mother reported daughter experienced dangerous lows on and off over past 4 years when changing reservoir.Cause of death is unknown.No official cause of death reported, but the mother feels like the low that occured after the daughter changed her reservoir killed her.The last blood glucose level was 97 mg/dl and was recorded on (b)(6) 2015 at 08:17 pm.The patient was wearing pump at the time of death.No further information available.

Manufacturer Narrative

Updated information 05-jul-2016: a visual inspection and a test for flow, leak and ventilation to the pcap connector were performed on the returned used device.A part of tubing was found damaged (stretched and cut) due to this it was leaking.The flow and ventilation tests were found within specifications.The reference samples were visually inspected and tested for flow, leak and ventilation to pcap connector.All test results were within specifications.The batch record (b)(4) was verified and found within specifications.Damages to the tubing can occur during several steps in manufacturing.To prevent systematic failures during manufacturing, unomedical uses online sampling plans according to iso 2859-1.Sample sizes are tested against specifications.Use of excessive force and/or tools or contact with certain substances such as disinfectants or perfumes may also cause damages to the tubing.The stretched and cut tubing caused it to leak.Updated information 18-apr-2016: the reference samples were visually inspected and tested for flow, leak and ventilation to pcc.All test results were within specifications.The batch record (b)(4) was verified and found 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 (b)(6) 2016: questions regarding event was asked but it has not been possible to obtain any additional information.See clinical evaluation from (b)(6) 2016 on (b)(6) 2016: unomedical is actively seeking further information on the incident.Unomedical is expected to submit a follow-up (or final) emdr report not later than 19-apr-2016.Clinical evaluation (b)(6) 2016: the mother reported death of daughter.Mother reported daughter experienced dangerous lows on and off over past 4 years when changing reservoir.Not enough information to perform a clinical evaluation.More information is necessary to evaluate incident and if death was or could be a result of pump or infusion set malfunction.

Event Description

(b)(4).The mother reported death of her diabetic daughter on pump therapy at home on (b)(6) 2015.Mother reported daughter experienced dangerous lows on and off over past 4 years when changing reservoir.Cause of death is unknown.No official cause of death reported, but the mother feels like the low that occured after the daughter changed her reservoir killed her.The last blood glucose level was 97 mg/dl and was recorded on (b)(6) 2015 at 08:17 pm.The patient was wearing pump at the time of death.No further information available.

• Brand Name: SILHOUETTE PARADIGM
• Type of Device: COMFORT
• 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: 5510120
• MDR Text Key: 40650484
• Report Number: 8021545-2016-00001
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2020
• Device Model Number: MMT-368
• Device Lot Number: 5096428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2015
• 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