MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM QUICK SET MMT-397T; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-397T

Device Problems Excess Flow or Over-Infusion (1311); Occlusion Within Device (1423)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 04/19/2018

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 called and reported that they experienced high blood glucose on (b)(6) 2018 with blood glucose of 533 mg/dl at the time of the incident.The customer was going as low as 48 and as high as 500 mg/dl.The customer was at 128 mg/dl at the time of the call.The customer used boluses to treat the high.The customer declined to troubleshoot the high.The customer was wearing the insulin pump during the incident.The customer reported sensor failure with fluctuations on the readings.The customer had issues with air bubbles in their set.The customer also reported a low of 52 to 55 mg/dl on (b)(6) 2018 while using pump auto mode.The customer felt herself crashing and treated with glucose tablets to get to 99 mg/dl.The customer felt like the pump over delivered.Troubleshooting was completed but did not resolve the issue.The insulin pump will be returned for analysis.

• Brand Name: PARADIGM QUICK SET MMT-397T
• 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: 7456332
• MDR Text Key: 106380536
• Report Number: 2032227-2018-02700
• 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: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-397T
• Device Catalogue Number: MMT-397T
• Device Lot Number: 5206496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/23/2018
• 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 Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 72