630G INSULIN PUMP MMT-1715K 630G BLACK MG

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-31 for 630G INSULIN PUMP MMT-1715K 630G BLACK MG manufactured by Medtronic Puerto Rico Operations Co..

Event Text Entries

[186164965] The pump was received with partially broken reservoir tube, missing retainer, missing reservoir tube o-ring, ase cracked behind the pump at the corner of the belt clip rails and cracked battery tube threads. A test p-cap and reservoir was installed and did not lock in place due to broken reservoir tube lip and missing retainer. Unable to perform the displacement test due to broken reservoir tube lip and missing retainer. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[186164966] Information received by the medtronic indicated that the insulin pump's top of battery compartment had crack. 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 Number3004209178-2020-92490
MDR Report Key9908924
Report SourceCONSUMER
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-01-28
Date Mfgr Received2020-03-23
Device Manufacturer Date2018-06-21
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 Name630G INSULIN PUMP MMT-1715K 630G BLACK MG
Generic NameARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
Product CodeOZO
Date Received2020-03-31
Returned To Mfg2020-02-05
Model NumberMMT-1715K
Catalog NumberMMT-1715K
Lot NumberHG2MEGQ
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

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.