MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722LNAP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-722LNAP

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems Hyperglycemia (1905); Hypersensitivity/Allergic reaction (1907); Irritation (1941)

Event Date 03/06/2019

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

Customer reported via phone call that the insulin pump was alleging under delivery.The customer¿s blood glucose level was 300 mg/dl at the time of incident and the current blood glucose level was 74 mg/dl.Customer sometimes experienced soreness, irritation and redness.Customer was treated with insulin for high blood glucose level.Customer was assisted with troubleshooting for high blood glucose level.Customer has been using insulin pump system within 48 hours of reported high blood glucose event.Customer reported that they have contacted their healthcare professional regarding the high blood glucose level.Customer was neither in emergency room, nor admitted into hospital, nor was emergency medical service dispatched as a result of high blood glucose level.Customer stated that the drive support cap appears normal.Customer stated that the displacement test.The insulin pump will not be returned for analysis.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722LNAP
• 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: 8411123
• MDR Text Key: 138536080
• Report Number: 3004209178-2019-66145
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00613994409546
• UDI-Public: (01)00613994409546
• 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: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-722LNAP
• Device Catalogue Number: MMT-722LNAP
• Device Lot Number: A3722LNAPJ
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/06/2019
• Initial Date FDA Received: 03/12/2019
• Date Device Manufactured: 06/24/2016
• 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
• Patient Age: 70 YR
• Patient Weight: 77