MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715K 630G BLACK MG; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1715K

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hyperglycemia (1905)

Event Date 02/20/2018

Event Type  malfunction  

Manufacturer Narrative

Insulin pump trace download analysis confirmed the pump alarmed power error, power loss alarm and replace battery alert.The power management tool confirmed power error, power loss alarm and replace battery alert was triggered battery loaded voltage (loaded vlith) was less than 3.5v for 4 consecutive hours due to connector resistance j6 /pcb 1.After disconnecting and reconnecting the internal battery connector on j6/pcb 1, the pump was monitored and functioned properly.Unit received with minor scratched lcd window, cracked keypad at select button, faded serial number label, cracked case(battery tube), cracked case and cracked retainer.

Event Description

Customer reported via phone call that they experienced high blood glucose level.Customer's blood glucose value was 330 mg/dl at the time of the incident.Customer stated that they had battery issues and insulin pump needs battery replacement.The customer was assisted with troubleshooting and declined for high blood glucose.The customer was treated with manual injection.Customer will return device for analysis.

• Brand Name: 630G INSULIN PUMP MMT-1715K 630G BLACK MG
• Type of Device: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• 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: 7624312
• MDR Text Key: 112067792
• Report Number: 3004209178-2018-83806
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169656840
• UDI-Public: (01)00643169656840
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/21/2018

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-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG1EH18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/24/2018
• Initial Date FDA Received: 06/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2016
• 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 Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 107