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

Model Number MMT-723NAL

Device Problems Failure to Read Input Signal (1581); Device Displays Incorrect Message (2591); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2018

Event Type  malfunction  

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 esc and act button of the insulin pump were unresponsive.Customer also reported the insulin pump had a weak battery alarm and the screen had a scratch making it harder to see the display.Blood glucose level at the time of the incident was not provided.The customer did not recall any significant events leading up to this issue.The customer stated that the time clock advances when monitored for one minute.Customer declines troubleshooting for other issues.The customer was advised the insulin pump has to be replaced and revert to back-up plan per health care provider's instruction.The product will be returned for analysis.

Manufacturer Narrative

Insulin pump received with intermittent button response due to corroded keypad traces.No button error alarm during testing.Insulin pump passed displacement test, self test, unexpected restart error test, off no power test and all operating currents tested within the spec range.Insulin pump was monitored and tested with no weak battery alarm and low battery alert noted.Insulin pump received with minor scratches on display window noted.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAL
• 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: 7661553
• MDR Text Key: 113197206
• Report Number: 3004209178-2018-87608
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169446458
• UDI-Public: (01)00643169446458
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-723NAL
• Device Catalogue Number: MMT-723NAL
• Device Lot Number: B3723NALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/08/2018
• Initial Date FDA Received: 07/03/2018
• Supplement Dates Manufacturer Received: 08/29/2018
• Supplement Dates FDA Received: 09/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2014
• 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 Age: 28 YR
• Patient Weight: 165