MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAB; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-523NAB

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Failure to Deliver (2338); Device Displays Incorrect Message (2591); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2018

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

Customer reported via phone call that the insulin pump had several issues.Customer¿s blood glucose was unknown at the time of incident.Customer stated that the insulin pump button was unresponsive, scratches on the screen making it hard to read the display, had a no delivery alarm, and reservoir thread was chipped and harder to screw in the reservoir.No troubleshooting was performed.The product is not expected to return for analysis.

Manufacturer Narrative

Device was received with a minor scratched lcd window and a broken battery tube threads.Device passed the self test, displacement test, basic occlusion test, occlusion test, prime test, rewind test and excessive no delivery test.No excessive no delivery alarm noted during the testing.All buttons functioning properly.No damage in the keypad assembly noted.The keypad connector j2 or lcd locked properly during visual inspection.No rainbow effect on screen noted during visual inspection.No clicking sound noted during the testing.Device primed properly.(b)(4).

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAB
• 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: 7640530
• MDR Text Key: 112468509
• Report Number: 3004209178-2018-85388
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169446380
• UDI-Public: (01)00643169446380
• 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,Followup
• Report Date: 11/05/2019

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-523NAB
• Device Catalogue Number: MMT-523NAB
• Device Lot Number: B2523NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2014
• 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: 52 YR
• Patient Weight: 180