MAUDE Adverse Event Report: MEDTRONIC MINIMED OTHER; SENSOR, GLUCOSE, INVASIVE

Model Number MMT-XXX

Device Problems Crack (1135); No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2017

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.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 on that the insulin pump had a blank display.The customer¿s blood glucose level was 6.4 mmol/l at the time of the incident.The customer noted after exiting the swimming pool the screen went blank and there was a large crack on the device.Customer noted changing the battery did not resolve the issue.Customer was advised to place the insulin pump into storage mode, remove the battery, and press and hold the back button until the screen turns off.The customer was advised a replacement insulin pump will be sent out and to use a backup plan per healthcare professional's recommendation.The insulin pump will be returned for analysis.Ship: 1 pump / return: 1 pump.

• Brand Name: OTHER
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• 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: 6822287
• MDR Text Key: 83844883
• Report Number: 2032227-2017-41136
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this an Adverse Event Report?: No
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/01/2017
• 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