MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM QUICK SET MMT-396T; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-396T

Device Problem Air Leak (1008)

Patient Problem Hyperglycemia (1905)

Event Date 12/26/2017

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 high blood glucose.Customer was able to troubleshoot during the call.The customer¿s blood glucose level was 400, 328, 318, 311, 267, 233, 300, 314 and 205 mg/dl.The customer was treated with an injection.The customer experienced symptoms such as nausea, not fill good.The customer was neither in emergency room, nor admitted into hospital as a result of low blood glucose.Based on customer report customer does allege pump was over delivering.The customer performed high pressure test and it did pass.The customer also states had one little spot about 3" from the reservoir, the spot is about 1/8" long bubble.The insulin pump will not be returned for analysis.Customer reported disconnecting the infusion set at the quick release.Customer reported that insulin exited during the fill tubing process.No product is expected to be returned.

• Brand Name: PARADIGM QUICK SET MMT-396T
• 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: 7176972
• MDR Text Key: 96811400
• Report Number: 2032227-2018-00539
• 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
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-396T
• Device Catalogue Number: MMT-396T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/26/2017
• 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: 54 YR
• Patient Weight: 127