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 Problems Erratic or Intermittent Display (1182); Device Displays Incorrect Message (2591); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2017

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.

Event Description

It was reported via phone call that the insulin pump had alarmed critical pump error.Customer's blood glucose was 4.7mmol/l at the time of the incident.It was reported that the insulin pump fell on the flood and was seriously bumped prior to the error.It was also reported that the insulin pump also had an audio anomaly and flashing white screen as a result.It was reported that the customer was advised that the insulin pump needed to be replaced and was advised to discontinue use of the insulin pump and to revert to the backup plan.The insulin pump will be returned for analysis.

Manufacturer Narrative

Unable to verify manufacture mode due to flashing display.The insulin pump was received with a constant blank flashing white light on the display and constantly beeping due to vertical cracked lcd controller.Unable to verify critical pump error (open book image) due to flashing display.The insulin pump had minor scratched lcd window and cracked select button keypad overlay.

• 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
• MDR Report Key: 6678763
• MDR Text Key: 78818206
• Report Number: 2032227-2017-24989
• 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: 08/31/2017

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-1711B
• Device Catalogue Number: MMT-1711B
• Device Lot Number: HG16JLW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/06/2017
• Initial Date FDA Received: 06/29/2017
• Supplement Dates Manufacturer Received: 08/17/2017
• Supplement Dates FDA Received: 08/31/2017
• 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