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 distributor,foreign report with the FDA on 2020-03-31 for 640G INSULIN PUMP MMT-1712K manufactured by Medtronic Puerto Rico Operations Co..

Event Text Entries

[186163852] (b)(4). Unit p-cap/reservoir locked properly in place. Unit received with cracked case (battery tube) and cracked battery tube threads. Unit received with unresponsive buttons, problem isolated to keypad assembly. Unable to perform displacement test or selftest due to unresponsive keypad. Unit received with corroded electronic assemblies. 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


[186163853] Information received by medtronic indicated that the the insulin pump got broken at the back of case. Insulin pump was not dropped. Insulin pump was replaced no harm requiring medical intervention was reported. The insulin pump will be returned for analysis.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004209178-2020-92486
MDR Report Key9908921
Report SourceDISTRIBUTOR,FOREIGN
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2019-10-06
Date Mfgr Received2020-03-23
Device Manufacturer Date2019-02-21
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
Returned To Mfg2020-02-05
Model NumberMMT-1712K
Catalog NumberMMT-1712K
Lot NumberHG36S21
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 2020-03-31

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