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

Model Number MMT-1711B

Device Problem Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2018

Event Type  malfunction  

Manufacturer Narrative

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 their insulin pump was damaged.Customer stated the screen was badly scratched making it hard to view the display.The customer¿s blood glucose level was 10.5 mmol/l at the time of the incident.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.Device was received with minor scratched lcd window, scratched keypad overlay, cracked select button keypad overlay, cracked battery tube threads, cracked case at corner of the belt clip rails and cracked case along the side of the battery tube.

• Brand Name: 640G INSULIN PUMP MMT-1711B
• 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: 7698280
• MDR Text Key: 114623236
• Report Number: 3004209178-2018-93301
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169739444
• UDI-Public: (01)00643169739444
• 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: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1711B
• Device Catalogue Number: MMT-1711B
• Device Lot Number: HG13WSD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/11/2018
• 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