MAUDE Adverse Event Report: MEDTRONIC MINIMED OTHER

Model Number MMT-XXX

Device Problems Air Leak (1008); High Test Results (2457)

Patient Problem Hyperglycemia (1905)

Event Date 05/13/2018

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

Customer¿s father reported via phone call that his daughter experienced high blood glucose level around 400 mg/dl.Customer state that the multiple air bubbles in the tubing.Customer decline troubleshoot for high blood glucose level.The insulin pump will not be returned for analysis.

• Brand Name: OTHER
• 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: 7564653
• MDR Text Key: 109890181
• Report Number: 2032227-2018-04387
• 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: consumer,other
• Type of Report: Initial
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• 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
• Date Manufacturer Received: 05/13/2018
• 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
• Treatment: PUMP MMT-1780KPK 670G PATHWAY BLACK MG; UNOMEDICAL
• Patient Outcome(s): Other
• Patient Age: 10 YR
• Patient Weight: 72