MAUDE Adverse Event Report: MEDTRONIC MINIMED INFST MMT-864T SURETPRDGM 2PK 6MM23N 21L; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-864T

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Blood Loss (2597)

Event Date 02/11/2018

Event Type  malfunction  

Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Event Description

Customer reported via phone that they received an insulin flow blocked alarm.Customer's blood glucose level at the time of the incident was unknown.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 insulin flow blocked.Customer reported that insulin also did not exit when attempting to push it through with a plunger.Customer was able to assemble another infusion and observed insulin exit the tubing.The product is expected to be returned.

• Brand Name: INFST MMT-864T SURETPRDGM 2PK 6MM23N 21L
• 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: 7298298
• MDR Text Key: 101129401
• Report Number: 2032227-2018-01651
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-864T
• Device Catalogue Number: MMT-864T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/11/2018
• Initial Date FDA Received: 02/26/2018
• 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 Age: 58 YR
• Patient Weight: 54