640G INSULIN PUMP MMT-1712B

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-1712B manufactured by Medtronic Puerto Rico Operations Co..

Event Text Entries

[186373171] (b)(4). Pump was received with a cracked case behind the pump near the battery tube compartment. Pump was received with a missing retainer, missing reservoir tube o-ring and broken reservoir tube lip. The test reservoir does not lock in place and unable to perform the displacement test due to missing retainer, missing reservoir tube o-ring and broken reservoir tube lip. 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


[186373172] Information received by medtronic indicated that the insulin pump got broken at the back of case. 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 Number3004209178-2020-92479
MDR Report Key9908904
Report SourceDISTRIBUTOR,FOREIGN
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2019-09-18
Date Mfgr Received2020-03-23
Device Manufacturer Date2016-05-11
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-1712B
Generic NamePUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
Product CodeOYC
Date Received2020-03-31
Returned To Mfg2020-02-05
Model NumberMMT-1712B
Catalog NumberMMT-1712B
Lot NumberHG116RE
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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