MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PRDGM INSULIN PUMP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-XXX

Device Problems Break (1069); Fluid/Blood Leak (1250); Mechanical Problem (1384); Device Difficult to Program or Calibrate (1496)

Patient Problems Bruise/Contusion (1754); Unspecified Infection (1930); Itching Sensation (1943); Skin Irritation (2076); Blood Loss (2597)

Event Date 07/01/2018

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

In the study, "glucose-responsive insulin delivery for type 1 diabetes: the artificial pancreas story", there was the inclusion of an insulin pump user survey across multiple brands.Nearly half of those who responded to the survey reported some form of insulin delivery problems, either due to the infusion set or the actual insulin pump.The pump issues in particular included: no delivery alarms, keypad issues, rewind malfunction, battery compartment problems, display anomalies, and o-ring leakage.The following infusion set problems were also noted: cannula blockage, leakage at the connection site, and kinking.Survey responders also experienced: site infection, bleeding, bruising, pain, soreness, irritation, itchiness, adhesion issues, and lipohypertrophy.Troubleshooting for these issues did not occur.No products have been returned for further analysis as a result of this survey.

• Brand Name: PRDGM INSULIN PUMP
• Type of Device: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer Contact: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386 ; 8185464805
• MDR Report Key: 8276611
• MDR Text Key: 134061757
• Report Number: 3004209178-2019-48137
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-XXX
• Device Catalogue Number: MMT-XXX
• Date Manufacturer Received: 01/01/2019
• 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