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 2019-11-29 for 640G INSULIN PUMP MMT-1712K manufactured by Medtronic Puerto Rico Operations Co..

Event Text Entries

[168461354] (b)(4). 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. 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


[168461355] It was reported that insulin pump had hardware low level failure for twice during self test. Customer? S blood glucose was unknown. Insulin pump will be returned for analysis.
Patient Sequence No: 1, Text Type: D, B5


[184371369] Device passed the self test. Format history file analysis confirmed pump error 63 (variable 3) due to open traces. Unable to perform the displacement test and the p-cap/reservoir will not lock properly due to missing retainer. Device received with missing reservoir tube o-ring and pillowing keypad overlay.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2032227-2019-125225
MDR Report Key9391430
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-11-29
Date of Report2019-11-29
Date of Event2019-11-05
Date Mfgr Received2019-11-22
Device Manufacturer Date2017-03-11
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 Name640G INSULIN PUMP MMT-1712K
Generic NamePUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
Product CodeOYC
Date Received2019-11-29
Model NumberMMT-1712K
Catalog NumberMMT-1712K
Lot NumberHG1QJQ4
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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