KIT MMT-1760KPK 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 company representative,foreig report with the FDA on 2020-03-31 for KIT MMT-1760KPK 670G PATHWAY BLACK MG manufactured by Medtronic Puerto Rico Operations Co..

Event Text Entries

[185967301] Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned. No conclusion can be drawn at this time. We therefore consider this report complete to the best of our knowledge.
Patient Sequence No: 1, Text Type: N, H10


[185967302] It was reported that the insulin pump had a critical pump error. Blood glucose level at the time of the incident was not provided. Customer stated the device was exposed to moisture before alarmed appeared. The customer was advised that the insulin pump would be replaced and agreed to return the device for analysis.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004209178-2020-92437
MDR Report Key9908799
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-20
Date Mfgr Received2020-03-20
Device Manufacturer Date2019-03-22
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactGERWIN DE GRAAFF
Manufacturer StreetCEIBA NORTE IND. PARK #50 ROAD
Manufacturer CityJUNCOS 00777-386
Manufacturer Country*
Manufacturer Postal00777-3869
Manufacturer Phone8185464805
Manufacturer G1MEDTRONIC PUERTO RICO OPERATIONS CO.
Manufacturer StreetCEIBA NORTE IND. PARK #50 ROAD
Manufacturer CityJUNCOS 00777-386
Manufacturer Country*
Manufacturer Postal Code00777-3869
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameKIT MMT-1760KPK 670G PATHWAY BLACK MG
Generic NameARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL
Product CodeOZP
Date Received2020-03-31
Model NumberMMT-1760KPK
Catalog NumberMMT-1760KPK
Lot NumberHG39HUE
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
10 2020-03-31

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