PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754WWS

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 2019-11-29 for PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754WWS manufactured by Medtronic Puerto Rico Operations Co..

MAUDE Entry Details

Report Number2032227-2019-125214
MDR Report Key9391393
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-11-29
Date of Report2019-11-29
Date of Event2019-11-24
Date Mfgr Received2019-11-24
Device Manufacturer Date2017-11-15
Date Added to Maude2019-11-29
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 NamePARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754WWS
Generic NamePUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
Product CodeOYC
Date Received2019-11-29
Model NumberMMT-754WWS
Catalog NumberMMT-754WWS
Lot NumberB5754WWSJ
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 2019-11-29

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