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

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problem Hypoglycemia (1912)

Event Date 11/10/2017

Event Type  malfunction  

Manufacturer Narrative

We have received data originating from a user-submitted medwatch report from our distributor (b)(4).We have no information on what kind of infusion set has possibly been involved in the described incident(s).We are seeking further information from medtronic.We expect to provide a final mdr report to fda within the next approximately 31 days.

Event Description

(b)(4).From a user submitted medwatch report received by unomedical via (b)(4): i have had three instances where my medtronic paradign pump has over delivered insulin to me and caused me to suffer terrible lows.In two instances i had to give myself glucagon injections.I have noticed that when priming the device it is consistently leaking and over delivering insulin.At this point, i don't feel safe using it but i am having trouble finding insulin that covers my needs with just injections.I find the product to be dangerous.Something is wrong with the mfg of the component that fit together.Either that or my pump is broken again.They need to fix it asap.

Event Description

Unomedical reference number: (b)(4).From a user submitted medwatch report received by unomedical via medtronic minimed: i have had three instances where my medtronic paradign pump has over delivered insulin to me and caused me to suffer terrible lows.In two instances i had to give myself glucagon injections.I have noticed that when priming the device it is consistently leaking and over delivering insulin.At this point, i don't feel safe using it but i am having trouble finding insulin that covers my needs with just injections.I find the product to be dangerous.Something is wrong with the mfg of the component that fit together.Either that or my pump is broken again.They need to fix it asap.

Manufacturer Narrative

We have received data originating from a user-submitted medwatch report from our distributor medtronic minimed.We have no information on what kind of infusion set has possibly been involved in the described incident(s).We are seeking further information from medtronic.We expect to provide a final mdr report to fda within the next approximately 31 days.23-apr-2018: as per today we have not been able to obtain further information.We will continue to seek this.If relevant, further information is obtained we will re-open this case.Update the case and provide a further follow-up emdr to fda.

Manufacturer Narrative

We have received data originating from a user-submitted medwatch report from our distributor medtronic minimed.We have no information on what kind of infusion set has possibly been involved in the described incident(s).We are seeking further information from medtronic.We expect to provide a final mdr report to fda within the next approximately 31 days.23-apr-2018: as per today we have not been able to obtain further information.We will continue to seek this.If relevant, further information is obtained we will re-open this case.Update the case and provide a further follow-up emdr to fda.

Event Description

Unomedical reference number: (b)(4).From a user submitted medwatch report received by unomedical via medtronic minimed: i have had three instances where my medtronic paradign pump has over delivered insulin to me and caused me to suffer terrible lows.In two instances i had to give myself glucagon injections.I have noticed that when npriming the device it is consistently leaking and over delivering insulin.At this point, i don't feel safe using it but i am having trouble finding insulin that covers my needs with just injections.I find the product to be dangerous.Something is wrong with the mfg of the component that fit together.Either that or my pump is broken again.They need to fix it asap.

Manufacturer Narrative

We have received data originating from a user-submitted medwatch report from our distributor medtronic minimed.We have no information on what kind of infusion set has possibly been involved in the described incident(s).We are seeking further information from medtronic.We expect to provide a final mdr report to fda within the next approximately 31 days.23-apr-2018: as per today we have not been able to obtain further information.We will continue to seek this.If relevant, further information is obtained we will re-open this case.Update the case and provide a further follow-up emdr to fda.24-apr-2018: by mistake b4 'date of this report' was not updated in followup 1 - this date is now updated (to 24-apr-2018).16-may-2018: we have received information that the infusion set type is the mmt-383 type of medtronic minimed silhouette paradigm.Two lots have been mentioned: 5175953 and 5199570.These lots are not affected by medtronic's recall fa-784.Medtronic informs that their help line contacted the customer in order to obtain additional information in relation to the reported incident but the customer declined to both provide additional information as well as conduct any troubleshooting.If we get no further information we wil close this case by submitting a later follow-up mdr within a month's time.

Event Description

Unomedical reference number: 1006406 from a user submitted medwatch report received by unomedical via medtronic minimed: i have had three instances where my medtronic paradign pump has over delivered insulin to me and caused me to suffer terrible lows.In two instances i had to give myself glucagon injections.I have noticed that when npriming the device it is consistently leaking and over delivering insulin.At this point, i don't feel safe using it but i am having trouble finding insulin that covers my needs with just injections.I find the product to be dangerous.Something is wrong with the mfg of the component that fit together.Either that or my pump is broken again.They need to fix it asap.We have received information that the infusion set type is the mmt-383 type of medtronic minimed silhouette paradigm.Two lots have been mentioned: 5175953 and 5199570.These lots are not affected by medtronic's recall fa-784.Medtronic informs that their help line contacted the customer in order to obtain additional information in relation to the reported incident but the customer declined to both provide additional information as well as conduct any troubleshooting.

• Brand Name: MEDTRONIC SILHOUETTE PARADIGM
• Type of Device: INSULIN INFUSION SET
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3, osted; lejre, 4320 ; DA 4320
• MDR Report Key: 7361006
• MDR Text Key: 103437303
• Report Number: 3003442380-2018-00015
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K162812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/16/2018

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 Expiration Date: 04/01/2020
• Device Model Number: N/A
• Device Lot Number: 5175953
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2018
• Initial Date FDA Received: 03/22/2018
• Supplement Dates Manufacturer Received: 02/28/2018; 02/28/2018; 02/28/2018
• Supplement Dates FDA Received: 04/23/2018; 04/24/2018; 05/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other