MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1780KPK 670G PATHWAY BLACK MG; ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL

Model Number MMT-1780KPK

Device Problems Circuit Failure (1089); Battery Problem (2885); Power Problem (3010)

Patient Problem Hyperglycemia (1905)

Event Date 09/29/2019

Event Type  malfunction  

Manufacturer Narrative

Unit power up properly after battery installation.Unit received with operating currents within spec.Unit passed selftest, rewind, seating, basic occlusion test, occlusion test, force sensor test and displacement test.The adapt tool confirmed the unloaded voltage (ul vlith) and loaded voltage (loaded vlith) was within spec range.No power error 25 or power loss alarm noted during testing or in the pump trace download.Pump error 63 (variable 12) was confirmed in the pump history, problem isolated to electronic assemblies.(b)(4).

Event Description

Information received by medtronic indicated that their insulin pump had power detected alarm and hardware low level failure alarm.Customer was unable to clear alarm.Customer reported that they performed self test and test was passed.No harm requiring medical intervention was reported.The insulin pump will be returned for analysis.

• Brand Name: PUMP MMT-1780KPK 670G PATHWAY BLACK MG
• Type of Device: ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer Contact: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869 ; 8185464805
• MDR Report Key: 10216226
• MDR Text Key: 197202659
• Report Number: 2032227-2020-139205
• Device Sequence Number: 1
• Product Code: OZP
• UDI-Device Identifier: 00763000190460
• UDI-Public: (01)00763000190460(17)211022
• 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: Other
• Type of Report: Initial
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/22/2021
• Device Model Number: MMT-1780KPK
• Device Catalogue Number: MMT-1780KPK
• Device Lot Number: HG2WZFF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Date Manufacturer Received: 06/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2018
• 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: 41 YR
• Patient Weight: 54