MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP; "ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL

Model Number MMT-7811NA

Device Problems Component Falling (1105); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hyperglycemia (1905); Unspecified Infection (1930)

Event Date 01/28/2018

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.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 the blood glucose was high.The customer reported that his transmitter was eaten by his dog.The customer has not been using the pump and pump battery is dead.The customer state that they were having an issue.The customer got sick went off insulin pump when initially off, sweated, didn't notice it dropped and fell out of body, and dog ate it.The customer stated blood glucose was high in the range of 500mg/dl, and had an infection.The customer treated with syringes.The customer also reported that they had a severe staff infection and medication caused issues not related to low or high blood glucose.The customer declined to troubleshoot for high blood glucose.The customer also declined to troubleshoot the pump and stated the pump is fine.The insulin pump will not be returned for analysis.

Manufacturer Narrative

The information provided with the initial report was incorrect.The correct information has been provided with this report.

Manufacturer Narrative

The information was incorrect with the initial report.The correct information has been provided with this report.

Manufacturer Narrative

The event was reported in error.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
• Type of Device: "ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL
• 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
• MDR Report Key: 7355752
• MDR Text Key: 102994019
• Report Number: 2032227-2018-02055
• Device Sequence Number: 1
• Product Code: MDS
• 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,Followup,Followup
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-7811NA
• Device Catalogue Number: MMT-7811NA
• Device Lot Number: A000394009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other
• Patient Age: 32 YR
• Patient Weight: 170