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 Erratic or Intermittent Display (1182)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/18/2017

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.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

Customer reported via phone call display anomaly on the insulin pump.Customer¿s blood glucose level was 3.6 mmol/l.Troubleshooting for display anomaly was performed.Customer advised the display flashed white and black.Customer was advised to discontinue use of the device and revert to a backup plan.Customer was advised that the device would be replaced and agreed to return the product for analysis.

Manufacturer Narrative

After battery installation device gave an unexpected blank/white flashing display followed by an unexpected intermittent beep alarm due to cracked lcd controller.Unable to verify missing segments or partial display due to blank display.Device received with minor scratches on case, cracked select button keypad overlay, stained keypad overlay, pillowing keypad overlay, cracked retainer, keypad overlay texture damage, corroded battery tube and minor scratches on lcd window.

• 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: 6794462
• MDR Text Key: 82879763
• Report Number: 2032227-2017-36805
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169662544
• UDI-Public: (01)00643169662544
• 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: 05/15/2018

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-1711B
• Device Catalogue Number: MMT-1711B
• Device Lot Number: HG12CAE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/18/2017
• Initial Date FDA Received: 08/15/2017
• Supplement Dates Manufacturer Received: 04/30/2018
• Supplement Dates FDA Received: 05/15/2018
• 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