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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2018

Event Type  malfunction  

Manufacturer Narrative

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 customer had power error detected and reservoir ring come away.The customer¿s blood glucose level was 3.9 mmol/l.The customer was assisted with troubleshoot for power error detected and the customer stated that pump has not been exposed to temperatures below 41°f.The customer was advised to clear the power loss alarm and complete the reservoir and tubing process.It was explained that the process should resolve the power error detected condition.The customer was assisted with troubleshooting for damage.Customer states reservoir ring come away but still lock in place.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 the self test, sleep current measurement, active current measurement, and the displacement test.Power error and low battery alarms due to j6 connector resistance issue.No unexpected replace battery now alarms noted during testing.Device was received with missing serial number label, cracked select button keypad overlay, case cracked behind the pump at the corner of the belt clip rails and cracked battery tube threads.

• 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: 7290717
• MDR Text Key: 100775600
• Report Number: 3004209178-2018-52638
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169739475
• UDI-Public: (01)00643169739475
• 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: 01/21/2019

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: HG1659U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/08/2018
• Initial Date FDA Received: 02/22/2018
• Supplement Dates Manufacturer Received: 01/18/2019
• Supplement Dates FDA Received: 01/21/2019
• 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