MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-723RNAP

Device Problems Erratic or Intermittent Display (1182); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2017

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 insulin pump alarmed unexpected restart and had a keypad anomaly.Troubleshooting was performed.The customer¿s blood glucose level was 83 mg/dl at the time of the incident.The customer reported that there was no temp basal programmed prior to the unexpected restart alarm and that insulin pump was not stored or not in used for an extended period of time.The customer also stated the alarm did not occur shortly during battery and was not recurring during normal use.The customer was advised to monitor and call back if the issue persist.Troubleshooting for button error/keypad anomaly was performed.The buttons were unresponsive and numbers were ramping without input during carbs input for bolus.The time on the clock advanced when monitored for one minute.The customer was advised that the insulin pump needed to be replaced and was advised to discontinue use of the insulin pump and to revert to the backup plan.The insulin pump will be returned for analysis.

Manufacturer Narrative

Pump monitored for several days.Pump received with intermittent button response due to corroded keypad traces.No button error alarm during testing.Unit received with all operating currents within spec and passed functional testing including the rewind, unexpected restart error test, basic occlusion test, occlusion test, prime test, excessive no delivery test and displacement test.No unexpected restart alarm anomalies noted.Pump received with minor scratched lcd window, cracked case at the display window corners, cracked lcd window, cracked belt clip slot, cracked battery tube threads, stained end cap sticker, stained address/serial number label and cracked reservoir tube lip.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAP
• 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
• MDR Report Key: 6867566
• MDR Text Key: 86588589
• Report Number: 2032227-2017-48423
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169221499
• UDI-Public: (01)00643169221499
• 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
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-723RNAP
• Device Catalogue Number: MMT-723RNAP
• Device Lot Number: A000290378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2017
• 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 Age: 66 YR
• Patient Weight: 164