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

Model Number MMT-723LNAH

Device Problems Device Displays Incorrect Message (2591); Positioning Problem (3009)

Patient Problem Hyperglycemia (1905)

Event Date 05/20/2017

Event Type  Injury  

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 the insulin pump alarmed motor error and a motor encoder position error and that they also experienced a high blood glucose level of 400 mg/dl at the time of the incident.The customer stated they had symptoms such as dry mouth and irritated but declined to troubleshoot the high readings.The customer was assisted with motor error troubleshooting.The customer¿s blood glucose level was 600 mg/dl at the time of the call.The customer stated that the drive support cap appeared normal.The customer stated that the insulin pump was not exposed to high magnetic fields.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

The insulin pump passed the rewind, basic occlusion, prime and displacement test.Pump received with stuck motor error alarm loop during bolus delivery.The motor was tested outside of the device and passed.The motor may have had and intermittent failure that was not detected during our testing.Unable to verify motor position encoder error alarm in the alarm history due to history file overwritten.The insulin pump was received with cracked reservoir tube lip, minor scratched lcd window and cracked battery tube threads.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAH
• 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: 6647093
• MDR Text Key: 77759263
• Report Number: 3004209178-2017-55694
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169513884
• UDI-Public: (01)00643169513884
• 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: 08/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-723LNAH
• Device Catalogue Number: MMT-723LNAH
• Device Lot Number: A5723LNAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/24/2017
• 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: 51 YR
• Patient Weight: 163