MAUDE Adverse Event Report: MEDTRONIC MINIMED SURE T; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-864

Device Problems Failure to Deliver (2338); Device Displays Incorrect Message (2591)

Patient Problem Hyperglycemia (1905)

Event Date 07/04/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

Event Description

Customer reported via phone that they received a no delivery alarm.Customer's blood glucose level at the time of the incident was 28.6 mmol/l.Customer was able to troubleshoot.Customer disconnected at the quick release and attempted to perform a fixed prime.Customer reported that insulin did not exit the infusion set tubing and the pump continued to alarm no delivery.Customer reported that insulin also did not exit when attempting to push it through with a plunger.The product is expected to be returned.

• Brand Name: SURE T
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire st.; northridge, CA 91325-1219
• MDR Report Key: 7251791
• MDR Text Key: 99353292
• Report Number: 2032227-2018-01342
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 20643169441655
• UDI-Public: (01)20643169441655(017)20210101
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2021
• Device Model Number: MMT-864
• Device Catalogue Number: MMT-864
• Device Lot Number: 5138177
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2016
• Date Device Manufactured: 02/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other