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

Model Number MMT-723RNAL

Device Problems Erratic or Intermittent Display (1182); Device Operates Differently Than Expected (2913)

Patient Problem Hyperglycemia (1905)

Event Date 06/13/2017

Event Type  malfunction  

Manufacturer Narrative

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 keypad anomaly.The numbers on the insulin pump kept scrolling up and they could not stop it.They had woken up with a high blood glucose and was going to input the numbers on the insulin pump when the error occurred.The customer took the battery out and inserted another battery.The insulin pump kept beeping with no alarm.The customer's blood glucose level was 344 mg/dl.The customer was advised to discontinue use of the device and revert to a back-up plan.The insulin pump was returned for analysis.

Manufacturer Narrative

The insulin pump passed all functional testing, including idle current test, run current test, self test, off no power test, unexpected restart error test, basic occlusion test, occlusion test, prime test, excessive no delivery test, displacement test and rewind test.No excessive no delivery alarm noted.Pump received with minor scratched display window and cracked battery tube threads.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAL
• 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: 6695654
• MDR Text Key: 79513534
• Report Number: 2032227-2017-26891
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169221482
• UDI-Public: (01)00643169221482
• 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: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-723RNAL
• Device Catalogue Number: MMT-723RNAL
• Device Lot Number: A000290380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2017
• 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: 68 YR