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

Model Number MMT-XXX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypoglycemia (1912)

Event Date 09/14/2017

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

The customer reported via phone call that they experienced a low blood glucose of 24 mg/dl with blood glucose of 24 mg/dl.The customer was in emergency room for four hours.The customer declined to troubleshoot.The insulin pump will not be returned for analysis.

Manufacturer Narrative

The information provided were incorrect with the initial report.The correct information has been provided with this report.

• 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: 6889058
• MDR Text Key: 87179072
• Report Number: 2032227-2017-52026
• 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,Followup
• Report Date: 07/19/2018

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-XXX
• Device Catalogue Number: MMT-XXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/14/2017
• Initial Date FDA Received: 09/23/2017
• Supplement Dates Manufacturer Received: 09/14/2017
• Supplement Dates FDA Received: 07/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• 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: 63 YR