MAUDE Adverse Event Report: UNOMEDICAL A/S INSULIN INFUSION SET SILHOUETTE PARADIGM MMT-378

Model Number MMT-378

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 04/04/2013

Event Type  Death  

Manufacturer Narrative

When unomedical received notification of this case from medtronic, the case was evaluated as a pump complaint case.Thus, it was not reported by unomedical.At a recent review unomedical has decided to report this case nevertheless simply because it is informed that an infusion set (silhouette paradigm mmt-378) manufactured by unomedical was presumably used.We have not received any information which points to the infusion set being specially 'suspect' regarding the reported fatal automobile crash on (b)(6) 2013.We are actively seeking further information regarding the reported claim.We aim at submitting a follow-up (or final) report no later than mid-january 2016.Unomedical's preliminary clinical evaluation on 09-dec-2015: it is reported that patient died in a car accident on (b)(6) 2013.Health conditions or any clinical data on patient prior to accident is not reported.It is by existing data not possible to make a clinical evaluation.

Event Description

Unomedical reference number: (b)(4).A (b)(6) male diabetic is receiving insulin via an insulin pump, an insulin reservoir and a medtronic silhouette paradigm mmt-378 infusion set.On 17-mar-2015 medtronic is contacted by litigation paralegal, (b)(6).The paralegal reports, that patient (b)(6) died in an automobile crash on (b)(6) 2013.She demands that medtronic in their presence shall investigate the 'equipment' which is in their possession.The involved insulin equipment include: insulin pump: mmt-522nas, serial no (b)(4).Insulin reservoir: mmt-326a.Insulin infusion set: silhouette paradigm mmt-378 (unknown lot number).Presently, no further information is available.

Manufacturer Narrative

When unomedical received notification of this case from medtronic, the case was evaluated as a pump complaint case.Thus, it was not reported by unomedical.At a recent review unomedical has decided to report this case nevertheless simply because it is informed that an infusion set (silhouette paradigm mmt-378) manufactured by unomedical was presumably used.We have not received any information which points to the infusion set being specially 'suspect' regarding the reported fatal automobile crash on (b)(6) 2013.We are actively seeking further information regarding the reported claim.We aim at submitting a follow-up (or final) report no later than mid-january 2016.Unomedical's preliminary clinical evaluation on 09-dec-2015: it is reported that patient died in a car accident on (b)(6) 2013.Health conditions or any clinical data on patient prior to accident is not reported.It is by existing data not possible to make a clinical evaluation.On 15-jan-2016 - unomedical close the case as no further information has been obtainable.

Event Description

(b)(4).Follow-up status 15-jan-2016: unomedical has not been able to obtain any further, relevant information regarding this case.We are not aware of any new information ever becoming available.We therefore consider this case as closed.Should any new relevant information become available, we will re-open the case and act appropriately - including informing the fda of such new information.End of follow-up status 15-jan-2016.A (b)(6) male diabetic is receiving insulin via an insulin pump, an insulin reservoir and a medtronic silhouette paradigm mmt-378 infusion set.On (b)(6) 2015 medtronic is contacted by litigation paralegal, (b)(6) the paralegal reports, that patient (b)(6) died in an automobile crash on (b)(6) 2013.She demands that medtronic in their presence shall investigate the 'equipment' which is in their possession.The involved insulin equipment include: insulin pump: mmt-522nas, serial no (b)(4).Insulin reservoir: mmt-326a.Insulin infusion set: silhouette paradigm mmt-378 (unknown lot number).Presently, no further information is available.

• Brand Name: INSULIN INFUSION SET SILHOUETTE PARADIGM MMT-378
• Type of Device: SILHOUETTE PARADIGM
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3, osted; lejre, DK-43 20; DA DK-4320
• Manufacturer (Section G): UNOMEDICAL A/S; aaholmvej 1-3, osted; lejre, DK-43 20; DA DK-4320
• Manufacturer Contact: aaholmvej 1-3, osted; lejre, DK-43-20 ; 548167000
• MDR Report Key: 5277200
• MDR Text Key: 33053191
• Report Number: 8021545-2015-00004
• 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
• Report Date: 01/15/2016

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 Model Number: MMT-378
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/18/2015
• Initial Date FDA Received: 12/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 39 YR
• Patient Weight: 66