MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 640G INSULIN PUMP MMT-1712W; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-1712W

Device Problems Device Displays Incorrect Message (2591); Naturally Worn (2988); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2017

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.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 replace battery now alarm on the insulin pump.Customer¿s blood glucose level was 233 mg/dl.Troubleshooting for the alarm was performed.Customer advised they replaced the battery on the device multiple times and the issue remained unresolved.Customer received the replace battery now alarm for the second time.Customer advised the display screen had several scratches on it and the buttons were worn out.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

Insulin pump passed sleep current measurement, active current measurement, self test and displacement test.No unexpected replace battery now alarm or power loss alarm noted during testing.Insulin pump was received with minor scratched lcd window, scratched case and cracked select button keypad overlay.(b)(4).

• Brand Name: 640G INSULIN PUMP MMT-1712W
• 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: 6623614
• MDR Text Key: 77297601
• Report Number: 3004209178-2017-53901
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169577701
• UDI-Public: (01)00643169577701
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1712W
• Device Catalogue Number: MMT-1712W
• Device Lot Number: HG0QTH1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Date Manufacturer Received: 08/28/2018
• 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
• Patient Age: 11 YR