MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 640G INSULIN PUMP MMT-1711H; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-1711H

Device Problems Erratic or Intermittent Display (1182); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2017

Event Type  malfunction  

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.The insulin pump involved in this event is the 640g insulin infusion pump, which is not marketed in the united states.However, the device is similar to the paradigm real-time insulin infusion pump, which is marketed in the united states.

Event Description

The customer reported via phone call that the insulin pump had critical pump error.The customer¿s blood glucose level was 5 mmol/l.The customer stated that the changed battery out and placed it back into the pump and then afterwards the pump screen started flashing white and saw the critical pump error icons.Customer reported that they received a critical pump error image on the pump screen.The customer was advised to discontinue use of the pump and recommended customer refer to back up plan per health care professional instructions.The customer was advised that the pump needs to be replaced.The insulin pump will be returned for analysis.

Manufacturer Narrative

The insulin pump was received with open book and critical pump error after battery installation.The pump had constant critical pump error alarm.Problem isolated to force sensor.

• Brand Name: 640G INSULIN PUMP MMT-1711H
• 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: 7119788
• MDR Text Key: 95068290
• Report Number: 2032227-2017-73630
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169739451
• UDI-Public: (01)00643169739451
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1711H
• Device Catalogue Number: MMT-1711H
• Device Lot Number: HG1NZDQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/26/2018
• 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