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 Bent (1059); No Flow (2991)

Patient Problem Hyperglycemia (1905)

Event Date 05/28/2018

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.

Event Description

The customer was reported via phone call that, the customer was visited to emergency room on (b)(6) 2018 for high blood glucose of 350 mg/dl.The previous blood glucose was 270 mg/dl and current blood glucose was 120 mg/dl to 124 mg/dl.The customer did not stay in hospital high blood glucose.The customer declined troubleshooting for high blood glucose.Customer mentioned to nurse the insulin pump is not delivering.Customer was currently in the emergency room with the pump alarming.Assisted customer in performing a 5.0 unit fixed prime and the insulin was exited.Customer also stated that, the infusion set cannula was bent.The sensor and reservoir will not be returned for analysis.

• 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: 7637980
• MDR Text Key: 112330502
• Report Number: 3004209178-2018-85236
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169507166
• UDI-Public: (01)00643169507166
• 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: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-523NAB
• Device Catalogue Number: MMT-523NAB
• Device Lot Number: B4523NABJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/28/2018
• Date Device Manufactured: 05/26/2016
• 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
• Treatment: MMT-326A; MMT-399
• Patient Outcome(s): Hospitalization
• Patient Age: 68 YR
• Patient Weight: 156