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

[186724282] 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


[186724283] It was reported that the customer experience high blood glucose levels. The customer's blood glucose level was 414 mg/dl. The customer did not mention how they treated. The customer did not mention any symptoms. The customer had been off the insulin pump for less than 48 hours. The auto mode on the insulin pump was not active and automatically adjusting insulin delivery during the event. Customer reports calibration required from the auto mode readiness screen. The insulin pump will not be returned for analysis.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004209178-2020-92434
MDR Report Key9908791
Report SourceCONSUMER
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-20
Date Mfgr Received2020-03-20
Device Manufacturer Date2020-01-16
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 NumberHG418GD
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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