PUMP MMT-1780KPK 670G PATHWAY BLACK MG

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-11-30 for PUMP MMT-1780KPK 670G PATHWAY BLACK MG manufactured by Medtronic Puerto Rico Operations Co..

MAUDE Entry Details

• Report Number: 2032227-2019-125389
• MDR Report Key: 9392234
• Report Source: OTHER
• Date Received: 2019-11-30
• Date of Report: 2019-11-29
• Date of Event: 2019-09-14
• Date Mfgr Received: 2019-11-26
• Device Manufacturer Date: 2017-08-23
• Date Added to Maude: 2019-11-30
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: GERWIN DE GRAAFF
• Manufacturer Street: CEIBA NORTE IND. PARK #50 ROAD
• Manufacturer City: JUNCOS 00777-386
• Manufacturer Postal: 00777-3869
• Manufacturer Phone: 8185464805
• Manufacturer G1: MEDTRONIC PUERTO RICO OPERATIONS CO.
• Manufacturer Street: CEIBA NORTE IND. PARK #50 ROAD
• Manufacturer City: JUNCOS 00777-386
• Manufacturer Postal Code: 00777-3869
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PUMP MMT-1780KPK 670G PATHWAY BLACK MG
• Generic Name: ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL
• Product Code: OZP
• Date Received: 2019-11-30
• Returned To Mfg: 2019-10-04
• Model Number: MMT-1780KPK
• Catalog Number: MMT-1780KPK
• Lot Number: HG20UQG
• Operator: LAY USER/PATIENT
• Device Availability: R
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
• Manufacturer Address: CEIBA NORTE IND. PARK #50 ROAD JUNCOS 00777-386 00777-3869

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-11-30