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

Model Number MMT-523LNAS

Device Problems Insufficient Flow or Under Infusion (2182); Detachment of Device or Device Component (2907)

Patient Problems Hyperglycemia (1905); Blood Loss (2597)

Event Date 07/20/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Event Description

Information received by medtronic indicated that they allege insulin pump was under delivering and drive support cap was flush.Customer experienced high blood glucose level and was treated with manual injection.Customer had been using insulin pump system within 48 hours of reported high blood glucose event.Troubleshooting was performed.No harm requiring medical intervention was reported.The insulin pump will be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAS
• 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; * 00777-3869
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer Contact: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869 ; 8185464805
• MDR Report Key: 10342897
• MDR Text Key: 200993944
• Report Number: 2032227-2020-155039
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169932982
• UDI-Public: (01)00643169932982
• 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: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-523LNAS
• Device Catalogue Number: MMT-523LNAS
• Device Lot Number: A5523LNASJ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/24/2020
• Date Device Manufactured: 12/12/2017
• 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: 79 YR
• Patient Weight: 140