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 05/27/2020

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 the insulin pump had an¿open book image¿on screen.No harm requiring medical intervention was reported.The insulin pump will be returned for analysis.

Manufacturer Narrative

Device received with critical pump error (open book) after battery installation and unable to download, problem isolated to electronic assembly.Unable to perform functional test including self test, rewind, prime/seating test, basic occlusion test, occlusion test, force sensor test and displacement test due to critical pump error.Force sensor zero offset measured within specification range.

• 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: 10103962
• MDR Text Key: 195137219
• Report Number: 2032227-2020-124365
• Device Sequence Number: 1
• Product Code: OZP
• UDI-Device Identifier: 00643169939219
• UDI-Public: (01)00643169939219
• 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: 06/28/2020

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-1780KPK
• Device Catalogue Number: MMT-1780KPK
• Device Lot Number: HG1WKNT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/27/2020
• Initial Date FDA Received: 05/31/2020
• Supplement Dates Manufacturer Received: 06/25/2020
• Supplement Dates FDA Received: 06/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2017
• 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: 45 YR