MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 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 Material Integrity Problem (2978)

Patient Problems Congestive Heart Failure (1783); Hyperglycemia (1905); Urinary Tract Infection (2120)

Event Date 07/26/2018

Event Type  Injury  

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

The customer¿s wife reported via phone call that they experienced high blood glucose level of 466 mg/dl after surgery on (b)(6) 2018 and the insulin pump had a blank display.The customer¿s blood glucose level was unknown at the time of incident and the current blood glucose level was 203 mg/dl.The customer treated high blood glucose level with insulin pump.Customer has been using insulin pump system within 48 hours of reported high blood glucose event.The drive support cap appears normal.Based on customer¿s report customer does not allege pump was under delivering.Customer states that the insulin pump display went blank immediately after pump exposure to moisture.The customer also reported that they were hospitalized due to urinary tract infection and congestive heart failure and was treated with pills and antibiotics.The device will be returned for analysis.

Manufacturer Narrative

Device passed the functional test, including the displacement test, rewind, basic occlusion test, occlusion test, prime test, excessive no delivery test and delivery accuracy test.No under delivery anomaly or over delivery anomaly noted.The stop (idle) current and run current measurement tests are within specification.Device also passed self test, off no power alarm test and unexpected restart error test.Device was programmed and monitored for seven days.No blank display noted.Device was received without the original battery cap.Unable to verify damage to the battery cap.Device had minor scratched display window, cracked case at display window corner, cracked battery tube threads and cracked reservoir tube lip.During visual inspection, the electronic assembly and the motor had moisture damage.

• 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 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 ; 8185464805
• MDR Report Key: 8136216
• MDR Text Key: 129433069
• Report Number: 2032227-2018-71250
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169513143
• UDI-Public: (01)00643169513143
• 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: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: A1723RNASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Initial Date Manufacturer Received: 11/26/2018
• Initial Date FDA Received: 12/05/2018
• Supplement Dates Manufacturer Received: 12/17/2018
• Supplement Dates FDA Received: 12/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2014
• 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
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Weight: 230