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

Model Number MMT-XXX

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Fluid/Blood Leak (1250)

Patient Problem Hyperglycemia (1905)

Event Date 12/13/2016

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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

Event Description

It was reported via phone call that they had a high blood glucose in the range of 500 mg/dl.It was reported that the customer had a site that fell off and insulin was leaking on their clothes.They were unsure what caused the site to fall off.The customer was delivering a bolus for the high blood glucose.No further details were given.The infusion set will not be returned for analysis.

• Brand Name: INFUSION SET
• 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: 6998313
• MDR Text Key: 90930702
• Report Number: 2032227-2017-63648
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 11/02/2017

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-XXX
• Device Catalogue Number: MMT-XXX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/28/2016
• Initial Date FDA Received: 11/02/2017
• 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: 51 YR