PUMP MMT-1782K 670G V4.11 MM

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 PUMP MMT-1782K 670G V4.11 MM manufactured by Medtronic Puerto Rico Operations Co..

Event Text Entries

[186343925] Insulin pump was received with missing reservoir tube o-ring and missing reservoir retainer. The p-cap does not lock properly into place. Unable to perform displacement test and reservoir unable to lock into place due to missing reservoir tube o-ring and missing reservoir retainer. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[186343926] Information received by the medtronic indicated that the insulin pump? S reservoir lip ring was popped off however reservoir was able to lock in place. 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 Number3004209178-2020-92467
MDR Report Key9908877
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2019-10-28
Date Mfgr Received2020-03-23
Device Manufacturer Date2019-05-08
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 NamePUMP MMT-1782K 670G V4.11 MM
Generic NameARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL
Product CodeOZP
Date Received2020-03-31
Returned To Mfg2020-02-05
Model NumberMMT-1782K
Catalog NumberMMT-1782K
Lot NumberHG3DRN2
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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