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

Model Number MMT-XXX

Device Problems Air Leak (1008); Bent (1059); Device Displays Incorrect Message (2591)

Patient Problem Skin Irritation (2076)

Event Date 05/30/2017

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

The customer reported via phone call that they received a no delivery alarm.Troubleshooting for no delivery alarm was performed.The customer's blood glucose level was unknown at the time of the incident.The customer was advised to disconnect at the quick release and was assisted with fixed prime, which they resulted with the insulin exiting.The customer was advised to change the site and the cannula was found to be bent.No delivery alarm was cleared.The customer was assisted with bent cannula troubleshooting.The customer stated that they stands up when inserting infusion set, had sufficient tissue and had no scar, hardened tissues and stretch marks.The cannula was bent after the first day of use.Recommended site and insertion techniques were reviewed.The customer mentioned skin irritation on the infusion set site and was also assisted with troubleshooting.The customer stated that the site that was irritated was bleeding but did not show signs of infection.The customer was advised proper site preparation.The customer also mentioned air bubbles in the reservoir but declined to troubleshoot.The insulin pump and reservoir will not be returned.The infusion set will be returned for analysis.

• 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: 6665302
• MDR Text Key: 78460395
• Report Number: 2032227-2017-23245
• Device Sequence Number: 1
• Product Code: MDS
• 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: 06/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2017
• 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: 05/30/2017
• 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
• Patient Age: 59 YR
• Patient Weight: 192