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

[186163542] (b)(4). Pump received with missing retainer and reservoir tube o-ring. Unable to perform the displacement test and p-cap/reservoir will not lock properly due to missing retainer. Pump not received with original battery cap. Battery cap cracked/damaged unknown.
Patient Sequence No: 1, Text Type: N, H10


[186163543] Information received by medtronic indicated that the insulin pump? S had damage reservoir lip ring and reservoir compartment. Customer stated that the little chrome piece on top of the battery cap came off and battery cap was also damage. Customer stated that reservoir was able to lock in place when insert into pump. 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 Number3004209178-2020-92477
MDR Report Key9908889
Report SourceCONSUMER
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2019-08-27
Date Mfgr Received2020-03-23
Device Manufacturer Date2017-02-07
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 NumberHG1N8KL
Device Expiration Date2018-03-02
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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