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

Model Number MMT-396T

Device Problem Obstruction of Flow (2423)

Patient Problems Bruise/Contusion (1754); Hyperglycemia (1905); Blood Loss (2597)

Event Date 02/29/2020

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.(b)(4).

Event Description

Customer reported via phone call that they experienced high blood glucose and they allege insulin pump was under delivering.The customer blood glucose level was 479 mg/dl at the time of incident.Customer was neither in emergency room, nor admitted into hospital, nor was emergency medical service dispatched as a result of high blood glucose.Customer was using insulin pump system within 48 hours of reported high blood glucose event.Customer reported that they received insulin flow blocked alarm.Customer stated the insulin was exited.Customer stated the cannula was not bent.Customer had a high blood glucose because of the blood and bruise on site.Customer treated with shot.The customer was assisted with troubleshooting and declined for high blood glucose.The insulin pump and reservoir will not be returned for analysis.

• 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 ; 8185464805
• MDR Report Key: 9791594
• MDR Text Key: 182126551
• Report Number: 2032227-2020-101611
• 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: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• 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
• Date Manufacturer Received: 02/29/2020
• 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
• Treatment: UNOMED SET
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Weight: 260