MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751LNAS; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-751LNAS

Device Problem Power Problem (3010)

Patient Problems Hyperglycemia (1905); Malaise (2359)

Event Date 11/01/2018

Event Type  malfunction  

Manufacturer Narrative

Pump has to reset time/date and received unexpected restart alarm after changing battery, problem isolated to interface board.Pump passed displacement test and all operating currents tested within the specification range.Pump was monitored and tested with no unexpected battery out limit alarm noted.

Event Description

The customer's parent reported via phone call that after each battery change the insulin pump requires to reset time and date.Customer had multiple battery out limit alarms.Customer was able to clear the alarm.Blood glucose level at the time of the incident was not provided but customer was not feeling well and had ketones and was treating the high blood glucose.The customer was advised that the insulin pump would be replaced and agreed to return the product for analysis.

• Brand Name: 530G INSULIN PUMP MMT-751LNAS
• 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 ; 8185464805
• MDR Report Key: 8886053
• MDR Text Key: 154441477
• Report Number: 2032227-2019-45557
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169933224
• UDI-Public: (01)00643169933224
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 08/12/2019

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-751LNAS
• Device Catalogue Number: MMT-751LNAS
• Device Lot Number: A5751LNASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Initial Date Manufacturer Received: 04/09/2019
• Initial Date FDA Received: 08/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2018
• 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: 14 YR
• Patient Weight: 109