MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-723NAP

Device Problems Erratic or Intermittent Display (1182); No Display/Image (1183)

Patient Problem Hyperglycemia (1905)

Event Date 05/30/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Currently it is unknown whether or not the device may have caused or contributed to the event.The device has been returned, but not yet evaluated.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 insulin pump had a blank display.The customer¿s blood glucose level was 400 mg/dl at the time of the incident.Customer stated that the insulin pump only shows half of the screen and would not show the full display.The customer was assisted with troubleshooting and stated that the battery compartment was not damaged or corroded and the insulin pump does not show any sign of physical damage.Customer also reported high blood glucose reading of 400 mg/dl, no treatment was mentioned and customer declined troubleshooting for high blood glucose issue.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump was returned for analysis.

Manufacturer Narrative

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

Manufacturer Narrative

The device was received with blank display due to missing battery tube spring.We were unable to perform all functional testing including the displacement test, operating currents test and verify battery out limit test, unexpected restart error test, rewind test, basic occlusion test, occlusion test, prime test and excessive no delivery test due to blank display.The insulin pump was received with minor scratched lcd window, cracked case at the display window corners, cracked battery tube threads and cracked reservoir tube lip.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAP
• 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
• MDR Report Key: 6677859
• MDR Text Key: 78720298
• Report Number: 2032227-2017-24909
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169446465
• UDI-Public: (01)00643169446465
• 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
• Report Date: 08/22/2017

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-723NAP
• Device Catalogue Number: MMT-723NAP
• Device Lot Number: B3723NAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/06/2017
• Initial Date FDA Received: 06/29/2017
• Supplement Dates Manufacturer Received: 06/06/2017; 08/10/2017
• Supplement Dates FDA Received: 07/31/2017; 08/22/2017
• 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: 77 YR
• Patient Weight: 88