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 Problem Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Event Description

Information received by medtronic indicated that insulin pump received open book image error.No harm requiring medical intervention was reported.The insulin pump will be returned for analysis.

Manufacturer Narrative

Device received with critical pump error due to moisture damage to force sensor.Device received with corroded electronic assemblies and corroded motor home switch.Misaligned force sensor cable and intermittent connection noted.Device unable to perform displacement test, rewind, prime/seating, basic occlusion, force sensor, occlusion, sleep current measurement, active current measurement, and self test due to critical pump error (open book image) alarm.

• 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
• 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: 10611100
• MDR Text Key: 209341290
• Report Number: 2032227-2020-184831
• Device Sequence Number: 1
• Product Code: OZP
• UDI-Device Identifier: 000000763000283520
• UDI-Public: (01)000000763000283520
• 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,Followup
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1780KPK
• Device Catalogue Number: MMT-1780KPK
• Device Lot Number: HG45BRZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2020
• 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: 42 YR