640G INSULIN PUMP MMT-1711K

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 2019-11-30 for 640G INSULIN PUMP MMT-1711K manufactured by Medtronic Puerto Rico Operations Co..

MAUDE Entry Details

Report Number2032227-2019-125347
MDR Report Key9392187
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-11-30
Date of Report2019-11-29
Date of Event2019-09-02
Date Mfgr Received2019-11-26
Device Manufacturer Date2017-05-04
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 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 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 Name640G INSULIN PUMP MMT-1711K
Generic NamePUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
Product CodeOYC
Date Received2019-11-30
Returned To Mfg2019-10-21
Model NumberMMT-1711K
Catalog NumberMMT-1711K
Lot NumberHG1TV51
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrR
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 2019-11-30

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