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 Number2032227-2019-125378
MDR Report Key9392223
Report SourceOTHER
Date Received2019-11-30
Date of Report2019-11-29
Date of Event2019-11-24
Date Mfgr Received2019-11-25
Device Manufacturer Date2019-08-12
Date Added to Maude2019-11-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactGERWIN DE GRAAFF
Manufacturer StreetCEIBA NORTE IND. PARK #50 ROAD
Manufacturer CityJUNCOS 00777-386
Manufacturer Postal00777-3869
Manufacturer Phone8185464805
Manufacturer G1MEDTRONIC PUERTO RICO OPERATIONS CO.
Manufacturer StreetCEIBA NORTE IND. PARK #50 ROAD
Manufacturer CityJUNCOS 00777-386
Manufacturer Postal Code00777-3869
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePUMP MMT-1780KPK 670G PATHWAY BLACK MG
Generic NameARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL
Product CodeOZP
Date Received2019-11-30
Model NumberMMT-1780KPK
Catalog NumberMMT-1780KPK
Lot NumberHG3NACQ
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC PUERTO RICO OPERATIONS CO.
Manufacturer AddressCEIBA NORTE IND. PARK #50 ROAD JUNCOS 00777-386 00777-3869


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-11-30

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