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

Model Number MMT-723NAS

Device Problems Retraction Problem (1536); Device Displays Incorrect Message (2591); Electromagnetic Compatibility Problem (2927)

Patient Problem Hyperglycemia (1905)

Event Date 10/09/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 the insulin pump alarmed motor error.The customer¿s blood glucose level was 440 mg/dl at the time of the incident.The customer stated that the insulin pump was stuck in rewind / prime loop.The customer stated that the drive support cap was normal and that the insulin pump was exposed to high magnetic fields and was able to complete the rewind process.Customer reported that a motor position encoder error was found in the insulin pump alarm history.Customer also reported to have experienced a high blood glucose of 440 mg/dl and treated with manual injection.No high blood glucose troubleshooting was performed.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump is being replaced and is expected to return for analysis.

Manufacturer Narrative

A complete analysis and testing of the insulin pump showed that it was functioning properly and passed all functional testing.After testing it was concluded that the device operated within specifications.Insulin pump passed the displacement test, rewind, basic occlusion, occlusion, prime/compromised force sensor system and excessive no delivery test.No motor error alarm noted.Motor passed motor test.Insulin pump was received with minor scratched lcd window, cracked belt clip slot, stained end cap sticker, stained address/serial number label and cracked reservoir tube lip.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAS
• 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: 6953161
• MDR Text Key: 89455219
• Report Number: 2032227-2017-58950
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169446472
• UDI-Public: (01)00643169446472
• 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: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-723NAS
• Device Catalogue Number: MMT-723NAS
• Device Lot Number: B4723NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2018
• 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 Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 175