MAUDE Adverse Event Report: MEDTRONIC MINIMED INFST MMT-943T MIO 2PK 6MM 23IN BLUE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-943T

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hypoglycemia (1912)

Event Date 06/05/2020

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

Customer reported via phone call possible over delivery of insulin, reservoir leak and fluid leak out of the reservoir and insulin pump.Troubleshooting was performed.Customer alleged the insulin pump over delivered insulin since their blood glucose levels went lower than usual.Customer's blood glucose level was 60 mg/dl and they treated via food.Customer advised they saw insulin leak out of the reservoir.No harm requiring medical intervention was reported.The insulin pump, reservoir and infusion set will be returned for analysis.

• Brand Name: INFST MMT-943T MIO 2PK 6MM 23IN BLUE
• 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 ; 8185464805
• MDR Report Key: 10156436
• MDR Text Key: 197096404
• Report Number: 2032227-2020-131063
• 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: Other
• Type of Report: Initial
• Report Date: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-943T
• Device Catalogue Number: MMT-943T
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/05/2020
• 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 Age: 40 YR
• Patient Weight: 124