MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-723NAS

Device Problems Fluid/Blood Leak (1250); Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591); Scratched Material (3020); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2018

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

The customer was reported via phone call that, the insulin pump had display screen was scratched and blurry and harder to read.The blood glucose was unknown at the time of the incident.The customer changing battery every 2.5 weeks and insulin pump has rejected new battery.The customer also stated that, the insulin squirting during priming and spits insulin from canula and motor sounds labored and louder during rewind and also had unexplained no delivery alerts becoming more frequent.The device is not expected to be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAS
• 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
• MDR Report Key: 7640758
• MDR Text Key: 112547158
• Report Number: 3004209178-2018-85501
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169202399
• UDI-Public: (01)00643169202399
• 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: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-723NAS
• Device Catalogue Number: MMT-723NAS
• Device Lot Number: B1723NASJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/29/2018
• Date Device Manufactured: 06/04/2013
• 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: 48 YR
• Patient Weight: 205