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 Problem Device Difficult to Program or Calibrate (1496)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 10/09/2020

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's daughter reported via phone call that customer were in emergency room and were hospitalized for unknown reason on unknown date with blood glucose level was unknown.Customer stated insulin pump had button error.Troubleshooting was performed.The insulin pump will be returned for analysis.

Manufacturer Narrative

Device passed the functional test, including the displacement test, rewind, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and delivery accuracy test at 0.0870 inches.The stop current and run current measurement tests are within specification.Device also passed self test, off no power alarm test and a21 error test.Device uploaded properly using care link.No button error alarm noted.Device had intermittent button response on the express bolus, esc, act, up arrow and down arrow buttons due to corroded keypad traces.No moisture damage noted on the electronic assembly or on the motor.Device had cracked case at display window corner, cracked battery tube threads, cracked reservoir tube and cracked reservoir tube lip.The test p-cap and reservoir does lock in place in the reservoir compartment.Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.

• 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: 10725961
• MDR Text Key: 212703157
• Report Number: 2032227-2020-195727
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 000000643169221505
• UDI-Public: (01)000000643169221505
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 12/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Date Manufacturer Received: 12/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2013
• 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: FRN-UNK-RSVR,UNOMED INF SET
• Patient Outcome(s): Hospitalization
• Patient Age: 90 YR
• Patient Weight: 115