MAUDE Adverse Event Report: MEDTRONIC MINIMED INFST MMT-941T MIO 2PK 6MM 18IN BLUE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-941T

Device Problems Bent (1059); Device Displays Incorrect Message (2591)

Patient Problem Hyperglycemia (1905)

Event Date 03/28/2018

Event Type  Injury  

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's mother reported via phone call that they experienced a high blood glucose level of 600 mg/dl.Customer's mother reported removing their infusion set and finding that the infusion set cannula was bent.Customer believes that the high blood glucose level was due to the bent infusion set cannula.Customer's mother reported that the elevated blood glucose level was treated with a manual injection of insulin.Customer's mother was unable to troubleshoot the bent infusion set cannula during the call as her son was at school.Customer's mother also reported receiving a no delivery alarm at which time the customer's blood glucose level was 400 mg/dl.Customer declined troubleshooting for the high blood glucose level as they believed it was attributable to the bent infusion set cannula.The infusion set is expected to be returned.

• Brand Name: INFST MMT-941T MIO 2PK 6MM 18IN BLUE
• 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: 7440346
• MDR Text Key: 105834097
• Report Number: 2032227-2018-02619
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 04/18/2018

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 Model Number: MMT-941T
• Device Catalogue Number: MMT-941T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/11/2018
• Initial Date FDA Received: 04/18/2018
• 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 Outcome(s): Other
• Patient Age: 9 YR
• Patient Weight: 28