MAUDE Adverse Event Report: UNOMEDICAL A/S MEDTRONIC MINIMED QUICK-SET PARADIGM; INSULING PUMP INFUSION SET

Model Number MMT-397

Device Problem Insufficient Information (3190)

Patient Problem Brain Injury (2219)

Event Date 07/12/2014

Event Type  Injury  

Manufacturer Narrative

Unomedical comments: we do not see data suggesting likelihood of an infusion set related incident.As we have not been able to obtain further information despite three attempts, we conclude that we will not get more information in the forseeable future.Should we get further, relevant information, we will re-open this complaint case and inform fda by means of a follow-up mdr report.

Event Description

(b)(4).Medtronic has been informed about a patient using a loaner insulin pump from medtronic.The patient is a teenage male who while driving crashed on (b)(6) 2014.It is alleged that the patient was insulin overdosed.He sustained a severe brain injury and has been in the hospital and long-term care for months.Unomedical was informed of the above (b)(6) 2017.The case was reassessed at unomedical on (b)(6) 2018 as we did not see data suggesting an infusion set related incident.We have unsuccessfully tried to obtain further information several times.For formal reasons we now report the case as a final mdr report.

• Brand Name: MEDTRONIC MINIMED QUICK-SET PARADIGM
• Type of Device: INSULING PUMP 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
• MDR Report Key: 7543741
• MDR Text Key: 109224799
• Report Number: 3003442380-2018-00020
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K106648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• 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: UNKNOWN
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2017
• 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): Hospitalization
• Patient Age: 17 YR