640G INSULIN PUMP MMT-1712K

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 640G INSULIN PUMP MMT-1712K manufactured by Medtronic Puerto Rico Operations Co..

Event Text Entries

[186162730] Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned. The device will be returned for analysis and further information will follow once the analysis has been completed. No conclusion can be drawn at this time. (b)(4). The insulin pump involved in this event is the 640g insulin infusion pump, which is not marketed in the united states. However, the device is similar to the paradigm real-time insulin infusion pump, which is marketed in the united states.
Patient Sequence No: 1, Text Type: N, H10


[186162731] It was reported via phone that the retainer ring that holds the reservoir has loosened. Customer's blood glucose was unknown at the time of the incident. Customer was advised the insulin pump will be replaced and agreed to return the device for analysis.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004209178-2020-92471
MDR Report Key9908881
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-19
Date Mfgr Received2020-03-19
Device Manufacturer Date2019-02-25
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 Name640G INSULIN PUMP MMT-1712K
Generic NamePUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
Product CodeOYC
Date Received2020-03-31
Model NumberMMT-1712K
Catalog NumberMMT-1712K
Lot NumberHG373Y3
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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