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

Model Number MMT-723NAH

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

Patient Problem Hypoglycemia (1912)

Event Date 11/20/2017

Event Type  Injury  

Manufacturer Narrative

This mdr related to the (b)(4) manufacturing site has been assigned a medwatch number from the medtronic minimed (b)(4) site, per variance 5.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 button error and that the numbers were ramping on their own.The customer added that the battery was removed and reinserted, resulting in a battery out limit alarm.Troubleshooting for button error/keypad anomaly was performed.Customer's blood glucose level was 179 mg/dl at the time of the incident.The customer also stated that numbers ramping on their own was the significant event leading to the keypad issues.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 customer also added that the experienced a low blood glucose level in the range of 24 mg/dl to 40 mg/dl the morning of the call.Troubleshooting for the low was not performed due to the button error.The insulin pump will be returned for analysis.

Manufacturer Narrative

Insulin pump was monitored for several days.Unit was received with all operating currents within specification and passed unexpected restart error test and displacement test.No unexpected battery out limit anomalies noted.Insulin pump was received with minor scratched lcd window, cracked belt clip slot, stained address/serial number label and cracked reservoir tube lip.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAH
• 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: 7110126
• MDR Text Key: 94569116
• Report Number: 2032227-2017-72437
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169202368
• UDI-Public: (01)00643169202368
• 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: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-723NAH
• Device Catalogue Number: MMT-723NAH
• Device Lot Number: B2723NAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2018
• 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: 76 YR
• Patient Weight: 135