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

Model Number MMT-1711K

Device Problems No Display/Image (1183); Patient Device Interaction Problem (4001)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/25/2019

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

It was reported that the insulin pump had blank display.The customer¿s blood glucose level was 7.8 mmol/l.The customer reported that the display was not blank less than 30 seconds and did not return.The customer was assisted with troubleshooting and customer reports display was blank currently.The customer stated the insert battery alarm did not display on the insulin pump screen.Customer states the contact on the battery cap was neither missing nor damage.Customer states battery compartment was neither damaged nor corroded.Customer states the spring was neither damaged nor corroded.Customer states the display did not return after insulin pump restart.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump will be returned for analysis.

Manufacturer Narrative

Device passed displacement test, sleep current measurement and active current measurement.Device was monitored and tested with no blank display noted.Device received with missing serial number label noted.The test reservoir stay locked in place noted.Device received error 63 alarm during self test and confirmed in the device history file due to broken trace on keypad assembly.

• Brand Name: 640G INSULIN PUMP MMT-1711K
• 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 ; 8185464805
• MDR Report Key: 9535030
• MDR Text Key: 173189862
• Report Number: 2032227-2019-140354
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00763000068998
• UDI-Public: (01)00763000068998
• 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: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1711K
• Device Catalogue Number: MMT-1711K
• Device Lot Number: HG284E2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/26/2017
• 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