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

Model Number MMT-1711P

Device Problems Crack (1135); Device Displays Incorrect Message (2591); Device Dislodged or Dislocated (2923)

Patient Problem Hyperglycemia (1905)

Event Date 10/24/2017

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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

Event Description

It was reported that customer had critical pump error image on the pump screen.The customer¿s blood glucose level was unknown.The customer stated that the insulin pump got damaged.The customer reported that ring was coming off and cracks around the lip of the reservoir opening.The customer was advised that the insulin pump will need to be replaced.The customer was advised to revert to back-up plan.The insulin pump will not be returned for analysis.

Manufacturer Narrative

Pump error 35 noted in the pump history and critical pump error alarm during testing due to moisture damage on the electronic assembly.Unable to perform the functional testing's including the self test, sleep current measurement, active current measurement, rewind test, prime test, seating test, basic occlusion test, occlusion test, force sensor test and displacement test due to critical pump error alarm.It was received with partially broken reservoir tube lip, missing reservoir tube retainer, missing reservoir tube o-ring, scratched case, minor scratched lcd window, cracked select button keypad overlay, stained keypad overlay, damaged keypad overlay texture and faded serial number label.Reservoir unable to lock into place due to missing reservoir retainer.

• Brand Name: 640G INSULIN PUMP MMT-1711P
• 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: 6987210
• MDR Text Key: 91005661
• Report Number: 2032227-2017-62657
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169662575
• UDI-Public: (01)00643169662575
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1711P
• Device Catalogue Number: MMT-1711P
• Device Lot Number: HG0U0RX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/24/2017
• Initial Date FDA Received: 10/30/2017
• Supplement Dates Manufacturer Received: 05/29/2018
• Supplement Dates FDA Received: 06/21/2018
• 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