MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-723RNAS

Device Problems Insufficient Flow or Under Infusion (2182); No Apparent Adverse Event (3189)

Patient Problems Congestive Heart Failure (1783); Hyperglycemia (1905)

Event Date 02/03/2019

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.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

The customer reported via phone call that they had high blood glucose level with the blood glucose level was over 600 mg/dl.It was also reported that the customer was hospitalized for 11 days due to heart issues.It was also reported that the insulin pump was not functioning properly and customer kept trying to bolus and insulin never came out.The customer declined troubleshooting for high blood glucose level.The insulin pump will be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAS
• Type of Device: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire st.; northridge, CA 91325-1219 ; 8185464805
• MDR Report Key: 8334625
• MDR Text Key: 135992442
• Report Number: 2032227-2019-01424
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169221505
• UDI-Public: (01)00643169221505
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-723RNAS
• Device Catalogue Number: MMT-723RNAS
• Device Lot Number: A000290012
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2019
• Date Device Manufactured: 04/14/2014
• 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
• Treatment: UNOMEDICAL SET, FRN-UNKNOWN-RSVR
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Weight: 86