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 consumer report with the FDA on 2020-03-31 for PUMP MMT-1780KPK 670G PATHWAY BLACK MG manufactured by Medtronic Puerto Rico Operations Co..

Event Text Entries

[186667022] 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


[186667023] The customer reported via phone call that they experienced high blood glucose. Blood glucose reading was 488 mg/dl and almost 500 mg/dl. It was unknown that if the insulin pump was in auto mode at the time of the incident. The insulin pump will not be returned for analysis.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004209178-2020-92382
MDR Report Key9908091
Report SourceCONSUMER
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-21
Date Mfgr Received2020-03-22
Device Manufacturer Date2019-10-11
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 NamePUMP MMT-1780KPK 670G PATHWAY BLACK MG
Generic NameARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL
Product CodeOZP
Date Received2020-03-31
Model NumberMMT-1780KPK
Catalog NumberMMT-1780KPK
Lot NumberHG3U03R
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 2020-03-31

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