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 Problems Low Battery (2584); Device Displays Incorrect Message (2591); Battery Problem (2885); Power Problem (3010)

Patient Problem Hyperglycemia (1905)

Event Date 05/28/2018

Event Type  Injury  

Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event.The device has been returned, but not yet evaluated.Further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Event Description

Customer reported via phone call that the insulin pump had unexpected battery power loss.The customer¿s blood glucose level was 257 mg/dl at the time of the incident.Customer did not receive a low battery alert prior to the replace battery alert or replace battery now alarm.Troubleshooting performed for unexpected battery power loss.The insulin pump will be returned for analysis.

Manufacturer Narrative

Pump passed the sleep current measurement, active current measurement, and displacement test.Pump trace download analysis confirmed the pump alarmed power error 25 and power loss alarm.The power management tool confirmed pump error 25 and power loss alarms were triggered when the loaded voltage was less than 3.5 volts for four consecutive hours due to connector resistance on the electrical board.After disconnecting and reconnecting the internal battery connector on the electrical board, the pump was monitored and functioned properly.

• 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: 7636664
• MDR Text Key: 112348662
• Report Number: 3004209178-2018-84941
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169656840
• UDI-Public: (01)00643169656840
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• 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: HG1F4DV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Date Manufacturer Received: 07/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2016
• 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 Age: 60 YR
• Patient Weight: 300