MAUDE Adverse Event Report: MEDTRONIC MINIMED INFST MMT-876 SURET PRDGM 10PK 8MM32N SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-876

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

Patient Problem Hyperglycemia (1905)

Event Date 11/24/2016

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. 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 call that they received a no delivery alarm that was resolved by changing their infusion set. The customer's blood glucose level at the time of the incident was 452 mg/dl. Customer treated the elevated blood glucose level with a bolus from her insulin pump. Customer was not able to troubleshoot at the time of the call. The infusion set is expected to be returned.

• Brand Name: INFST MMT-876 SURET PRDGM 10PK 8MM32N
• 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: 7225544
• MDR Text Key: 98471761
• Report Number: 2032227-2018-01059
• 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: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 07/31/2020
• Device Model Number: MMT-876
• Device Catalogue Number: MMT-876
• Device Lot Number: 5115467
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/24/2016
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 01/29/2018 Patient Sequence Number: 1